Quality Assurance Specialist

Quality Management Specialist

7-month contract

Remote - EST Hours

Key Responsibilities

• Perform detailed review of batch records for API, drug product, and finished goods to support product release
• Support lot disposition activities in accordance with GMP and regulatory requirements
• Identify trends and discrepancies during batch record and quality event review
• Initiate and manage quality events including deviations, investigations, CAPAs, and change controls within a Quality Management System (QMS)
• Collaborate with internal teams and external partners (e.g., contract manufacturers) to resolve quality issues and support product release timelines
• Review analytical and quality documentation, including stability reports, OOS/OOT results, and related data
• Support root cause investigations and implementation of corrective and preventive actions
• Assist in the development and maintenance of specifications, master batch records, and bill of materials
• Ensure compliance with applicable GMP regulations and internal quality standards

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related scientific discipline
• 5+ years of experience in pharmaceutical or biotechnology industry within QA, QC, or manufacturing support
• Demonstrated experience with batch record review and product release activities in a GMP environment
• Strong knowledge of GMP regulations, including FDA 21 CFR Parts 210 and 211
• Experience managing deviations, investigations, CAPAs, and change controls
• Familiarity with Quality Management Systems (e.g., TrackWise or similar)
• Experience working with external partners or contract manufacturing organizations (CMOs) is preferred
• Exposure to biologics or monoclonal antibody products
• Strong attention to detail, organizational, and problem-solving skills
• Effective communication and ability to collaborate across cross-functional teams