Onsite Batch Release QA Specialist II

NCBioImpact; Winston-Salem (NC); On-site; USD 68,000 - 86,000; Full time

Job summary

NCBioImpact in Winston-Salem, NC seeks a contractor Quality Assurance Specialist II, Batch Release to review manufacturing, labeling, and analytical records for completeness and compliance with cGMP requirements.

You will collaborate with Manufacturing, Quality Control, Supply Chain, and Regulatory teams to resolve documentation issues, assess quality events, and support timely material and product disposition. The role emphasizes data integrity and regulatory alignment.

Qualifications

• BS in life sciences or related field with at least 2 years in regulated environment
• Experience reviewing batch records and quality documentation for completeness, accuracy, data integrity, traceability
• Knowledge of cGMP, FDA/ISO frameworks
• Detail-oriented with strong judgment and ability to elevate quality risks
• Ability to organize and prioritize multiple assignments in a fast-paced environment

Responsibilities

• Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance; identify discrepancies and coordinate resolution
• Compile and perform initial quality review of batch disposition documentation; verify records and assess quality events
• Maintain accurate records in GMP databases and tracking systems; data entry and status updates
• Monitor production and non-production activities for compliance with cGMP; document status updates
• Support deviation investigations, root cause analysis, CAPAs, and effectiveness activities; evaluate impact on materials and disposition timelines
• Review and provide quality input on SOPs, change controls, and controlled documents
• Support implementation and continual improvement of regulated quality systems
• Track batch review status, deficiencies, release cycle times, and quality risks; escalate barriers to Quality Management
• Collaborate with cross-functional partners to resolve discrepancies and support timely disposition
• Maintain current knowledge of relevant regulations and quality practices

Skills

Attention to detail

Documentation review

Regulatory compliance

Data integrity

Cross-functional collaboration

Education

Bachelor’s degree in life sciences or related field

Associate degree with 4+ years relevant experience

Tools

cGMP systems

Quality databases

Deviation management tools

Job description

NCBioImpact in Winston-Salem, NC seeks a contractor Quality Assurance Specialist II, Batch Release to review manufacturing, labeling, and analytical records for completeness and compliance with cGMP requirements.

You will collaborate with Manufacturing, Quality Control, Supply Chain, and Regulatory teams to resolve documentation issues, assess quality events, and support timely material and product disposition. The role emphasizes data integrity and regulatory alignment.