Location: Acton, MA
Company: Innova Solutions
5AM - 5PM, 12 hour shift. Working B1 Crew. Weekends are included. Holidays included as the needs of the business warrant. Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required.
Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs routine manufacturing batch production record review in support of product
release in accordance with specifications and SOPs. Assist Operations by providing quality oversight and guidance for atypical events, backssing complex biologics manufacturing issues for forward processing.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing audit readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, c GMP regulations, and other industry guidelines. Reviews, approves and provides guidance
for quality master data Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data May support the Quality approval of Master Batch Records. Supports the Quality review and closure manufacturing deviations. Other duties as assigned. Knowledge of science generally attained through studies resulting in a B. S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 6-10years of relevant experience in a regulated environment with 2-4 years focused on product quality preferred Demonstrated ability to independently backss complex manufacturing and automation issues Knowledge of biotech cell culture, protein purification, bulk and finished product manufacturing is required Knowledge of US and EU c GMP regulations and guidance.
Knowledge of manufacturing batch record execution and review, maintenance execution approval, inventory management, and deviation management and approval is desirable Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Thank you! Sankalp Agnihotri Associate Recruiter PAY RANGE AND BENEFITS: Pay Range: $54.50 - $59.60 per hour. Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & shop coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) Clearly Rated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : / Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-xyz X.
Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (Hire Genics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U. S. C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy. PDN-9ad9cf8-be31-2dd46990b9fe
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