Quality Assurance Specialist
GForce Life Sciences, Trenton, NJ, United States
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
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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
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