Location: Brighton, MI
Company: Bryllan
atmosphere. Bryllan differentiates itself from our competitors by living our values of Integrity, Quality and Service. Quality Assurance Associates will participate in the generation, review, approval and training in support of c GMP quality systems and will be responsible for Quality Assurance activities in one or more suites for manufacturing operations.
As a member of the quality assurance team, associates are responsible to: Develop, review, approve and/or maintain documents that support both Quality Assurance and Operations. This may include Batch Records, Protocols and Reports (Engineering, Validation, Qualification, Stability, etc. ), Risk backssments, Process Flow Diagrams, Standard
Operating Procedures (SOP's), Investigations, and any other technical documents as required. Lead/represent QA on project teams in support of new product and manufacturing activities.
Review and approve incoming materials including but not limited to active medical materials, excipients, components, and packaging materials. Perform Quality oversight during manufacturing operations, including identifying and implementing process improvements through change control, investigations of non-conforming material, equipment, processes, etc. and review of the manufacturing documentation (batch records, logbooks, analytical testing data, protocol(s), etc. ) Perform review and approval of executed
documents. Assist in the identification, action, and resolution of changes and issues during manufacturing activities.
Develop and implement SOPs specifically related to CGMP quality systems, operations, and the facility, including training and training file maintenance. Assist in management of quality systems on a company-wide basis, including document control, vendor quality, training, CAPA, change management, auditing, validation/qualification programs, and non-conformance investigations. Behavioral Expectations include: Strong work ethic and ability to accomplish tasks without supervision Exhibits leadership, both by work and example, Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment, Excellent interpersonal skills with the ability to communicate effectively, Basic computer skills (proficient in Microsoft Office applications), Excellent communication skills, both written and verbal, Possess honesty and integrity with a commitment to the highest legal and ethical standards, Treats every person with courtesy and respect, Knowledge of CGMP and regulatory principles, Commitment to quality in the manufacturing process, Ability to independently analyze and resolve complex issues, Strong sense of initiative, accountability, and responsibility Ability to independently analyze and resolve complex issues The following qualifications are the minimum required for this role:5+ years of experience in the medical/biotech industry.
Comprehensive knowledge of c GMP and c GMP Quality Systems.4-year degree in a scientific discipline.
data volume databases. • Knowledge of SOA, Microservices and or Event based Architectures. • Solid knowledge of testing embedded product software and software QA methodologies and tools• Automation Testing experience using Languages (Python/ Java/ C++)• Experience in Automation Testing using tools (UI Automator), API Testing (JUnit) Interested candidates can send their updated resumes at xyz X@global- Job Posted by Applicant Pro
today's complex design and manufacturing issues. We offer a competitive salary, rich benefits package, and opportunities for growth. We offer a competitive wages, a rich benefits package including, medical, dental, vision, paid time off (PTO), paid holidays and 401K plan with matching.
The quality Engineer is expected to provide technical, clerical, and EMS audit support to operations quality. The quality Engineer will also provide on the job training of production associates. Essential Functions: Assemble, Submit, and achieve on-time approval of PPAP packages/workbooks. Create and update Process Flow, PFMEA, and Control Plan for new and existing products. Get IMDS approvals and work
with the program team(s) to secure other PPAP-related documentation. For new product or engineering change launches, Review and establish the feasibility of Customer Specifications/Standards and print GD&T Develop product testing/inspection methods and coordinate associated gage/test-fixture development Create Gage Instructions; Inspection Check Sheets; and Quality Guides Review and drive improvement of Process Books and Work Instructions with Process, Manufacturing, and Application Engineers.
Facilitate and Lead Production Team member training Ensure Document and Records Control Develop, maintain, and apply Lessons Learned from effective Safe Launch implementation and resulting inspection
data to drive Continuous Improvement methods, forms, check sheets, and other documentation Facilitate, Develop, Track implementation of, and Audit Corrective and Preventive Action reports as needed (in support of reacting to safe launch inspection data and operational launch feedback).
Participate in and support Customer and Supplier visits, audits, and other launch-related meetings Regular & prompt attendance at work Interacting with clients & coworkers; professional & respectful. Overtime and rotating shift, where applicable Qualifications Minimum five (5) years hands-on experience in Quality Assurance/Quality Control preferably in the North American Automotive Industry.
Bachelor's or Associate's degree in Engineering, Packaging, or equivalent experience Demonstrated experience/expertise with PPAP submissions and approvals in a fast-paced production environment APQP GD&T (Geometric Dimensioning & Tolerancing) PFMEA and Control Plan development and writing Check-fixture/Gage development and build Work and gage instructions development and writing MSA/Gage R & R, including Planning, Organizing, Performing, Analyzing and Reporting Process Studies (Capability) , including Planning, Organizing, Performing and Reporting Excellent verbal and written communication skills Experience working with external customers Experience working with Stellantis MMI Engineered Solutions is an equal-opportunity employer
on weeknights or on weekends. Required Skills 4+ years of direct experience in software quality assurance automation Familiar with Agile/SCRUM Methodology and SDLC Strong Excel spreadsheet experience (creating test cases and documentation) Automated Testing with Cucumber and/or Selenium Profile Love to teach Willing to share experience and knowledge If you think you fit the aforementioned requirement, kindly get back to us with your updated resume to email: Posted by Applicant Pro
and thrive in value-based care. We are searching for a Manager, Clinical Documentation Integrity - Quality Assurance to join the team. This Subject Matter Expert will support documentation improvement and coding within practices participating in value-based contracts.
This position is critical to our practices' ability to provide better care to Medicare beneficiaries and the CDI Lead is expected to be an exemplar of regulatory compliance. The CDI QA Lead will lead quality assurance program development and CDI QA initiatives. The CDI Lead must be detail-oriented, service-minded, possess strong verbal and written communication skills, and be fluent in (or willing and able to master) Google
Suite tools. We are looking for individuals who genuinely believe that Aledade's model of physician-led ACOs can improve quality and lower cost. This position will work remotely within the US and includes periodic travel to Aledade's Headquarters in Bethesda, MD and assigned markets.
Primary Duties: Partners with key stakeholders to lead clinical documentation and coding quality assurance initiatives & program development. Ensures compliance with third party and State and Federal regulations. Delivers progress reports to leadership regarding CD Quality program initiatives (e. g. audit reports) Serve as a Subject Matter expert for regulatory compliance, clinical documentation, coding,
and billing. Master auditor. Audits staff to assure a minimum of 95% accuracy and recommends education and training related to results.
Provides input to the staff performance evaluation completed and conducted by the Manager. Required Qualifications: Active nursing credential as Registered Nurse (RN) Bachelor's degree in Health Information Management or related healthcare field. 10 years of experience in lieu of the degree Preferred Experience, Skills, and Abilities: 4 years of experience in a health plan or health system setting 2 years of experience in Risk Adjustment 4+ years of management experience Previous experience in a quality assurance program and extensive knowledge of state and federal regulations and guidelines pertaining to documentation and coding.
Thorough understanding of medical coding guidelines and regulations including compliance, reimbursement, and the impact of diagnosis documentation on risk adjustment payment models. Complete understanding of acuity levels for specific patient populations and strong clinical knowledge with the ability to interpret clinical documentation. Experience working directly with physician practices and individual providers to achieve demonstrable improvement of the accuracy and completeness of documentation and coding.
Subject matter expertise on the Risk Adjustment program, methodology, and impact to value-based contracts across multiple lines of business (Medicare, Medicaid, & Commercial). Master's degree in health related fields. One or more of the following active credentials: RHIA - Registered Health Information Administrator (RHIA) - AHIMA RHIT - Registered Health Information Technician (RHIT) - AHIMA Certified Coding Specialist (CCS) - AHIMA Certified Documentation Improvement Practitioner (CDIP) - AHIMA Certified Clinical Documentation and Certification - Outpatient (CCDS-O) - ACDIS Certified Risk Coder (CRC) - AAPC Certified Professional Medical Auditor (CPMA) - AAPC Certified Professional Biller (CPB) - AAPC Rural Health Coding & Billing Specialist (RH-CBS) - Arch Pro Coding Community Health Coding & Billing Specialist (CH-CBS) - Arch Pro Coding Physical Requirements: Sitting for prolonged periods of time.
Extensive use of computers and keyboard. Occasional walking and lifting may be required. Flexibility to travel up to 10% of the time. Who We Are: Aledade, a public benefit corporation, exists to empower the most transformational part of our health care landscape - independent primary care.
We were founded in 2014, and since then, we've become the largest network of independent primary care in the country - helping practices, health centers and clinics deliver better care to their patients and thrive in value-based care. Additionally, by creating value-based contracts across a wide variety of payers, we aim to flip the script on the traditional fee-for-service model. Our work strengthens continuity of care, aligns incentives, and ensures primary care physicians are paid for what they do best - keeping patients healthy. If you want to help create a health care system that is good for patients, good for practices and good for society - and if you're eager to join a collaborative, inclusive and remote-first culture - you've come to the right place.
What Does This Mean for You? At Aledade, you will be part of a creative culture that is driven by a passion for tackling complex issues with respect, open-mindedness and a desire to learn. You will collaborate with team members who bring a wide range of experiences, interests, backgrounds, beliefs and achievements to their work - and who are all united by a shared passion for public health and a commitment to the Aledade mission.
In addition to time off to support work-life balance and enjoyment, we offer the following comprehensive benefits package designed for the overall well-being of our team members: Flexible work schedules and the ability to work remotely are available for many roles Health, dental and vision insurance paid up to 80% for employees, dependents, and domestic partners Robust time off plan 21 days of PTO in your first year 2 Paid Volunteer Days & 11 paid holidays12 weeks paid Parental Leave for all new parents6 weeks paid sabbatical after 6 years of service Educational Assistant Program & Clinical Employee Reimbursement Program401(K) with up to 4% match Stock options And much more!
At Aledade, we don't just accept differences, we celebrate them! We strive to attract, develop, and retain highly qualified individuals representing the diverse communities where we live and work. Aledade is committed to creating a diverse environment and is proud to be an equal opportunity employer. Employment policies and decisions at Aledade are based on merit, qualifications, performance, and business needs. All qualified candidates will receive consideration for employment without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, or interactionual orientation.
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