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Quality Assurance Associate III:
The Quality Assurance Associate III is an advanced level position with hands-on QA experience in a pharmaceutical environment. Working independently and under minimum supervision, the individual will be working primarily in quality operations providing quality assurance support to in-house production, testing and systems and Regulatory team. The individual will be interacting with cross-functional groups such as Quality Control, Manufacturing and Analytical Development as well as with third party contractors.
Specific Duties and Responsibilities:
- Perform a wide variety of quality assurance activities to ensure compliance with procedures, applicable US and international regulatory requirements for drug substances products under clinical development and commercial production
- Review and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications, stability protocols and reports
- Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
- Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
- Support the reserve sample program; perform incoming quality attribute inspections; review and disposition incoming raw materials
- Perform line clearance
- Perform product complaints investigations
- Support continuous improvement of quality operations; author new, revise existing and may review department procedures and/or forms
- Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
- Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
- Assist in review of regulatory submissions
Preferred Experience:
- Minimum 6 years of experience performing quality functions in pharmaceutical and/or biotech related fields
- Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
- Excellent interpersonal and verbal and written communication skills
- Good working knowledge of quality systems cGMP standards applicable to clinical and commercial drug substances
- Works independently with minimum supervision to accomplish goals
- Relies on extensive experience and judgment to resolve simple to moderately complex issues
- Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments
- Prior experience with regulatory inspections is desired
- BS or equivalent in biology, chemistry or related science