Summary:
The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.
Responsibilities:
Provides oversight for CMO Batch Production Records.
Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
Assists with Document Control and other QA functions.
Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
Gives guidance to CMO as needed and ensure CMO is compliant with BMS Quality standards.
Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
Escalates critical quality problems to Senior Management in a timely manner.
Skills or Requirements:
Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
Ability to Coordinate Quality oversight and working with other site groups.
Ability to review Quality documents and ensuring compliance to GMP. Documents to include batch records, logs, and others.
Ability to be an effective communicator to Management, and line staff.
Ability to work with other manufacturing teams to implement business objectives.
Must be very detail oriented and be able to quickly detect errors within documentation.
Education/Experience:
BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
About Yoh, A Day & Zimmermann Company:
Founded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.
Company Website: https://www.yoh.com/
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