Senior QA Specialist - QC Lab Operations

Position summary

The Senior QA Specialist – QC Laboratory Operations is an experienced QA professional responsible for providing independent Quality Assurance review, guidance, and compliance support for Analytical and Microbiology laboratory operations within a regulated cell therapy manufacturing environment. This role applies advanced knowledge of cGMPs, laboratory quality expectations, and data integrity principles to ensure testing activities meet internal and regulatory requirements while maintaining a high state of readiness for audits and inspections.

This position is required to be onsite in Winston Salem, NC.

Primary Responsibilities: 

Essential Duties & Responsibilities

• Ensures quality and compliance for Analytical and Microbiology laboratory operations in alignment with cGMP requirements, internal quality standards, and regulatory expectations.

• Perform QA review and approval of laboratory documentation including analytical raw data, microbiological test results, environmental monitoring data, and associated data packages to ensure accuracy, completeness, and data integrity.

• Review and support laboratory quality events including deviations, OOS/OOT investigations, environmental monitoring excursions, and associated CAPA activities.

• Review and approve change controls, laboratory methods, equipment qualification documentation, validation protocols/reports, and laboratory SOPs to ensure compliance with regulatory and internal quality requirements.

• Conduct routine GxP walkthroughs of QC laboratory areas to identify compliance risks, drive timely resolution of observations, and promote inspection readiness.

• Serves as QA lead for laboratory inspection readiness activities and provides QA representation during internal audits, regulatory inspections, and quality assessments.

• Provides QA direction for analytical testing, microbiological methods, and laboratory quality expectations supporting cell therapy manufacturing through cross-functional collaboration with QC Laboratories, Manufacturing, Quality Systems, ASAT, and Regulatory Affairs.

Education/Training

Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific discipline required. Advanced degree (MS or equivalent) preferred.

Experience

• Minimum 8 years of Quality Assurance or Quality Control experience in a regulated biopharmaceutical, biologics, cell therapy, or sterile manufacturing environment.

• Experience reviewing laboratory data under cGMP requirements.

• Experience supporting laboratory investigations including deviations, OOS, OOT, and environmental monitoring excursions.

• Experience supporting internal audits or regulatory inspections preferred.

Knowledge

• Strong understanding of cGMP regulations, 21 CFR Parts 210/211, 21 CFR Part 1271, and ICH guidelines.

• Knowledge of ALCOA+ data integrity principles and laboratory documentation standards.

• Understanding of analytical instrumentation, microbiological testing methods, method validation, and equipment qualification

Skills

• Strong analytical and problem-solving abilities. • Excellent attention to detail and quality decision-making.

• Strong communication and cross-functional collaboration skills.

• Ability to manage multiple priorities in a fast-paced GMP manufacturing environment.

• Ability to identify compliance risks and support implementation of corrective actions.