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