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.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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