Quality Assurance Specialist 2, Batch Release Contractor
About The Position
The Quality Assurance Specialist II, Batch Release supports Quality Operations by reviewing executed manufacturing, packaging, labeling, and laboratory records used for material and product disposition. The role verifies that documentation is complete, accurate, traceable, and compliant with approved procedures, specifications, data integrity requirements, and current Good Manufacturing Practice (cGMP) requirements. The Specialist works with Manufacturing, Quality Control, Supply Chain, and other functions to resolve documentation issues, assess quality events, and support release decisions based on complete and compliant records. This is a contractor position located onsite in Winston-Salem, North Carolina. It is not eligible for ProKidney benefits or remote/hybrid work. Schedule flexibility, including overtime, may be required based on business needs.
Requirements
- Bachelor’s degree in life sciences, engineering, quality, or a related field and at least two years of relevant experience in a regulated pharmaceutical, biotechnology, medical device, or similar environment; or an associate degree and at least four years of relevant experience. An equivalent combination of education and experience may be considered.
- Working knowledge of cGMP requirements, quality systems, deviation management, root cause analysis, and CAPA processes.
- Experience reviewing executed batch records, manufacturing documentation, laboratory records, or quality documentation for completeness, accuracy, data integrity, traceability, and compliance.
- Strong attention to detail, sound judgment, and the ability to identify, communicate, and escalate quality risks.
- Ability to organize and prioritize multiple assignments, meet deadlines, and deliver accurate work in a fast-paced environment.
- Must be eligible to work in the United States without work visa or residency sponsorship.
Nice To Haves
- Direct experience supporting material or product disposition in a pharmaceutical or biotechnology environment.
- Familiarity with applicable FDA, EU, and ISO regulatory frameworks.
Responsibilities
- Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance; identify discrepancies and coordinate their resolution before disposition.
- Compile and conduct initial quality review of batch disposition documentation, confirm required manufacturing and testing records are complete, and verify applicable deviations, investigations, and other quality events are assessed or resolved before recommending batches for final disposition.
- Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.
- Monitor production and non-production activities for cGMP compliance and promptly document and escalate observed issues.
- Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; assess and document potential impacts of quality events on affected materials, batches, and disposition timelines.
- Review and provide quality input on standard operating procedures, change controls, protocols, and other controlled documents.
- Support implementation, maintenance, and continuous improvement of regulated quality systems and procedures.
- Track and report batch review status, documentation deficiencies, release cycle times, recurring discrepancies, quality risks, and other performance indicators; escalate barriers that may affect compliant and timely disposition to Quality Management.
- Participate in internal, customer, and regulatory audits and support timely responses to audit observations, as assigned.
- Collaborate with Manufacturing, Quality Control, Supply Chain, Regulatory, and other cross-functional partners to resolve documentation discrepancies, obtain required information, communicate batch review status, and support compliant and timely material and product disposition.
- Maintain current knowledge of relevant regulations, industry standards, and quality practices.
- Perform other duties and quality-related assignments as needed.
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What This Job Offers
Career Level
Mid Level
