Medical Technologist or Medical Laboratory Scientist or Medical Laboratory | Lincolnton, NC

of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.

Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.

Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate.

Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.

Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively

address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers

the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute. Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile medical dosage forms, and general support activities within the Microbiology group in the Quality Control Department.

An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities

also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs.

The individual will author and/or revise procedures/methods, as appropriate. II. Essential Functions: Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance. Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct

of project activities and to assure project timeline understanding and deliverable are met, as appropriate.

Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities. Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable. Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.

Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. III. Position Requirements: Education or Equivalent: Bachelor's degree in chemistry or closely related physical science. Experience: : Education: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.

Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Basic understanding of instrument operations and troubleshooting skills in multiple techniques Ability to identify aberrant/out of spec data and limited interpretation of data expected Excellent written and verbal communications skills with internal and external customers -------------------------------------------------------------------------------------- Thanks & Regards Kiran comear Senior Recruiter Email: xyz X@ Desk Number: 732-412-xyz X Ext 259 Direct Number: 732-398-xyz X Website: Address: 517 Route 1 South, Suite 1115 Iselin, NJ 08830 In my absence, you may contact Kowshik Lead 732-627-xyz X xyz X@

routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.

Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate. Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities.

Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.

Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability

to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Education & Experience: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience

and limited complexity. The duties may include, but are not limited to: Interacts with all levels of lab staff and management to ensure the NSL Quality Management System (QMS) is suitable and fit-for-purpose. Monitors operations to verify adherence to quality plans and requirements; analyzes and investigates adverse quality trends or conditions; and initiates and monitors corrective actions.

Evaluates methods and procedures for suitability. Provides input and support to the development of new or adopted laboratory methods. Demonstrates commitment to compliance with the ISO/IEC 17025 standard and other quality standards as appropriate. Assures that the QMS is established, implemented,

and maintained in conformance with internal and external requirements. Manages document and record control. Writes standard operating procedures, manuals, and reports; and designs checklists, worksheets, and forms; to support day-to-day activities.

Organizes and conducts audits and/or management reviews (MR). Conducts internal audits in a professional and logical manner, maintaining objectivity to identify fact-based evidence, and providing on Communicates all audit findings to Management and assists with the corrective action process by facilitating investigations. Assists in planning and developing training programs for NSL personnel. Manages FOIA (Freedom of Information Act) requests.

Requirements Conditions of Employment You must be a US Citizen or US National.

Individuals who were born male after 12/31/1959 must be Selective Service registered or exempt. Subject to satisfactory adjudication of background investigation and/or fingerprint check. Successful completion of one-year probationary period, unless previously served. Direct Deposit: Per Public Law 104-134 all Federal employees are required to have federal payments made by direct deposit to their financial institution. Successfully pass the E-Verify employment verification check. To learn more about E-Verify, including your rights and responsibilities, visit E-Verify at www. e-verify.

gov/ Qualifications Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement, including specialized experience and/or education, as defined below. BASIC REQUIREMENT FOR THE 0401 SERIES: Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. or Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. BASIC REQUIREMENT FOR THE 1320 SERIES: Degree: physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.

or Combination of education and experience: Course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education. BASIC REQUIREMENT FOR THE 0403 SERIES: Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.

or Combination of education and experience: Courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education. BASIC REQUIREMENT FOR THE 1382 SERIES: Degree: food technology, or dairy technology, microbiology, biology, chemistry, physics, or a related discipline or field of biological or physical science.

The course work must have been comprised of at least 30 semester hours in the basic biological and physical sciences, and included at least 20 semester hours in food technology and closely related subjects, or 20 semester hours in subjects that can be applied directly to food technology. or Combination of education and experience: Courses equivalent to a major, including the course work specified, as shown in A above, plus appropriate experience or additional education.

FOR THE GS-09 GRADE LEVEL FOR THE 0401/1320/0403/1382 JOB SERIES: Applicants must have one year of specialized experience (equivalent to the GS-07 level) that may have been obtained in the private or public (local, county, state, Federal) sectors which demonstrates: Performing the duties associated with a Quality Management System accredited to ISO 17025 International Standard and AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and medicals. Performing corrective action processes with limited oversight including initiating, investigating, performing root cause analysis.

Auditing laboratory functions and writing reports of findings. Using certified reference material, proficiency testing programs and quality control charting related to quality assurance practices. OR 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree in courses relating to each individual basic requirement per job series. Note: Equivalent combinations of education and experience are qualifying for this grade level. FOR THE GS-11 GRADE LEVEL FOR THE 0401/1320/0403/1382 JOB SERIES: Applicants must have one year of specialized experience (equivalent to the GS-09 level) that may have been obtained in the private or public (local, county, state, Federal) sectors which demonstrates: Performing and monitoring a Quality Management System accredited to ISO 17025:2017 International Standard and AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and medicals under the direction of supervisor or senior employee.

Handling corrective action processes including initiating, investigating, performing root cause analysis and assisting in implementing actions.

Auditing laboratory functions and collaborating with management to address findings. Maintaining records to ensure the accuracy and defensibility of the laboratory and audit data. OR 3 years of progressively higher level graduate education leading to a Ph. D. degree or Ph. D. or equivalent doctoral degree in courses relating to each individual basic requirement per job series. Note: Equivalent combinations of education and experience are qualifying for this grade level. TRANSCRIPTS are required if: This position requires specific coursework or a degree in a specific field to be basically qualified.

You are qualifying for the position based on education. You are qualifying for this position based on a combination of experience and education. This education must have been successfully completed and obtained from an accredited school, college, or university COMBINATION OF EDUCATION & EXPERIENCE AT THE GS-09/11 GRADE LEVEL: Applicants may have combinations of successfully completed education and specialized experience to meet total qualification requirements. The total percentages must equal at least 100 percent to qualify for that grade level.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e. g. Peace Corps, Ameri Corps) and other organizations (e. g. professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education Please see above for education qualification requirement information.

Additional information Career Transition Assistance Plan (CTAP), Reemployment Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): Visit the OPM website for information on how to apply as a CTAP, RPL, or ICTAP eligible. To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When backssed through a score-based category rating method, CTAP/ICTAP applicants must receive a rating of at least 85 out of a possible 100.

First time hires to the federal government normally start at the lowest rate of the salary range for the grade selected. Travel, transportation, and relocation expenses will not be paid. Any travel, transportation, and relocation expense associated with reporting for duty will be the responsibility of the selected employee. This is an interdisciplinary position and may be filled in any of the job series/position titles listed. In addition to the specialized experience requirements, applicants must submit proof that they meet the educational requirements for at least one of the series described in the announcement.

Applicants may only be appointed to job series/position titles for which they meet all experience and educational requirements. Promotion Potential: If you are selected for a position with further promotion potential, you will be placed under a career development plan, and may be non-competitively promoted if you successfully complete the requirements and if recommended by management. However, promotion is neither implied nor guaranteed. Worksite Information: This position may be eligible to telework up to four days per week, based upon the duties of the position.

This position may also be eligible for flexible work arrangements as determined by agency policy and any applicable collective bargaining agreements. Additional information regarding ad hoc, occasional, or reoccurring telework may be obtained at a later time from the hiring manager or program during the hiring process. Benefits A career with the U. S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.

Opens in a new window Learn more about federal benefits. Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered. How You Will Be Evaluated You will be evaluated for this job based on how well you meet the qualifications above. Applications will be evaluated in accordance with Office of Personnel Management's (OPM) Delegated Examining Procedures and USDA policy using category rating.

Applicants who meet basic minimum qualifications will be placed in one of three categories: Best Qualified, Well Qualified, or Qualified. Within these categories, applicants eligible for veteran's preference will receive selection priority over non-veterans. Category placement will be determined based on applicants' quality of experience and the extent they possess the following knowledge, skills, and abilities (KSA) or competencies: Laboratory Operations Quality Assurance Your application, including the online backssment Questionnaire, will be reviewed to determine if you meet (a) minimum qualification requirements and (b) the resume supports the answers provided to the job-specific questions.

Your resume must clearly support your responses to all the questions addressing experience and education relevant to this position. Those determined to be in the best qualified category will be referred to the selecting official for consideration. Note: If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your score may be adjusted to more accurately reflect your abilities, or you may be found ineligible.

Please follow all instructions carefully. Errors or omissions may affect your rating. Providing inaccurate information on Federal documents could be grounds for non-selection or disciplinary action up to including removal from the Federal service. To preview the application questionnaire, please visit: apply. usastaffing. gov/View Questionnaire/12258250 Benefits A career with the U. S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.

Opens in a new window Learn more about federal benefits. Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered. Required Documents As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.

The following documents are required for your applicant package to be complete. Our office cannot be responsible for incompatible software, your system failure or downtime, etc. Encrypted documents will not be accepted. Failure to submit required, legible documents may result in loss of consideration. Resume that includes: 1) personal information such as name, address, contact information; 2) education; 3) detailed work experience related to this position as described in the major duties including work schedule, hours worked per week, dates of employment; title, series, grade (if applicable); 4) other qualifications; and 5) supervisors name and phone number for each work period listed and whether or not they may be contacted for reference checks.

If education is required or you are using education to qualify, you must submit a copy of your college transcripts. An unofficial copy is sufficient with the application if it includes your name and the necessary course information; however, if you are selected, you will be required to submit official transcripts prior to entering on duty. Education must have been successfully obtained from an accredited school, college or university.

If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U. S. education program. For further information, visit the following: Foreign Education Evaluation. All transcripts must be in English or include an English translation.

If claiming veterans' preference, you must submit a DD214, Certificate of Release from Active Duty, which shows dates of service and discharge under honorable conditions. If currently on active duty you must submit a certification of expected discharge or release from active duty service under honorable conditions within 120 days after the date the certification is submitted. The certification must be on the letterhead of the appropriate military branch and include the dates of military service. Veterans' preference must be verified prior to appointment. Without this documentation, you will not receive veteran's preference and your application will be evaluated based on the material(s) submitted.

If claiming 10-point veterans' preference you must provide the DD214 or certification requirements (see above bullet), plus the proof of entitlement of this preference as listed on the SF-15 Application for 10-point Veterans' Preference. The SF-15 should be included but is not required. Failure to submit these documents could result in the determination that there is insufficient documentation to support your claim for 10-point preference. For more information on veterans' preference visit FEDSHIREVETS Surplus or displaced employees eligible for CTAP, RPL, or ICTAP priority must provide: proof of eligibility (RIF separation notice, notice of proposed removal for declining a transfer of function or directed reassignment to another commuting area, notice of disability annuity termination), SF-50 documenting separation (as applicable), last performance appraisal that is at least fully successful or its equivalent, and your most recent SF-50 noting position, grade level, and duty location with your application per 5 CFR 330.

Worker's Compensation Separation: Agency certification of inability to place employee AND Notification of Separation OR Separation SF-50.

Disability Annuity Termination: Notification from OPM of disability annuity termination AND Separation SF-50 of the last position held. Military Reserve or National Guard Technician Special Disability Retirement Annuity under 5 U. S. C. 8337(h) or 8456: Certification of special disability retirement annuity from a military department or National Guard Bureau AND Separation SF-50 of the last position held. How to Apply Please read the entire announcement and all instructions before you begin. You must complete this application process and submit all required documents electronically by 11:59p.

m. Eastern Time (ET) on the closing date of this announcement. Applying online is highly encouraged. We are available to assist you during business hours (normally 8:00a. m. - 4:00p. m. Monday - Friday). If applying online poses a hardship, contact the Agency Contact listed below well before the closing date for an alternate method. All hardship application packages must be complete and submitted no later than noon ET on the closing date of the announcement in order to be entered into the system prior to its closing.

This agency provides reasonable accommodation to applicants with disabilities on a case-by-case basis; contact the Agency Contact to request this. Step 1: Create a USAJOBS account (if you do not already have one) at www. usajobs. gov. It is recommended that as part of your profile you set up automatic email notification to be informed when the status of your application changes. If you choose not to set up this automatic notification, then you will have to log into your USAJOBS account to check on the status of your application. Step 2: Create a Resume with USAJOBS or upload a Resume into your USAJOBS account.

You may want to customize your resume to ensure it documents duties and accomplishments you have gained that are directly related to this position in order to verify that qualifications are met. In addition, your resume must support your responses to the online questionnaire (you may preview the online questionnaire by clicking on the link at the end of the How You Will Be Evaluated section of the job announcement). Step 3: Click " Apply Online" and follow the prompts to complete the Occupational Questionnaire and attach any additional documents that may be required. You can update your application or documents anytime while the announcement is open.