Senior QA Specialist - QC Lab Operations

Position Summary:

The Senior QA Validation Specialist, QC Laboratory Operations provides independent Quality Assurance oversight and compliance support for Analytical and Microbiology laboratory operations within a regulated autologous cell therapy manufacturing environment. This role exercises independent judgement on complex quality matters, ensuring QC validation activities are executed in accordance with applicable cGMP requirements, internal quality standards, and regulatory expectations, with specific emphasis on method qualification, equipment and instrument validation, data integrity, and inspection readiness. The QA Specialist partners closely with QC, Validation, and Quality Systems to maintain a robust state of control.

This is located onsite in Winston Salem, NC.

Essential Duties & Responsibilities:

• Provide QA oversight for Analytical and Microbiology laboratory operations in alignment with cGMP requirements, internal procedures, and applicable regulatory expectations.
• Review and approve documentation, including (but not limited to):
  • Method lifecycle documentation, including method qualification, validation, transfer, and periodic review for both microbiological and analytical assays.
  • QC laboratory equipment and instrument life cycle documentation, including IQ/OQ/PQ, calibration strategies, and associated change controls.
  • Review and approve analytical equipment CSV protocols and final reports.
  • SOPs
• Review and support laboratory quality events, including deviations, OOS/OOT investigations, EM excursions, laboratory incidents, and associated CAPA activities.
• Ensure compliance with data integrity principles, ALCOA+ expectations, and applicable electronic record/electronic signature requirements.
• Review and approve laboratory change controls, risk assessments, CAPAs, and protocol/report packages related to QC systems, instruments, and methods.
• Conduct routine GxP walkthroughs of QC laboratory areas to identify compliance risks, reinforce procedural adherence, and support inspection readiness.
• Serve as QA representative during internal audits, and regulatory inspections related to QC laboratory operations.
• Partner with leadership and cross-functional stakeholders to drive timely resolution of quality issues and support continuous improvement of laboratory quality systems.
• Provide mentoring, technical guidance, and quality oversight to junior staff as needed, without direct people-management responsibility.

Qualifications:

• Education/Training: Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or related scientific discipline.

• Experience:
  • 8+ years of progressive QA or QC quality experience in a GMP-regulated pharmaceutical, biotech, or cell therapy environment.
  • Demonstrated experience supporting microbiology and/or analytical QC laboratory operations.
  • Experience reviewing and supporting method qualification, validation, transfer, and lifecycle documentation.
  • Experience with laboratory instrument qualification/validation and associated change control processes.
  • Working knowledge of investigations, CAPA, deviations, and audit/inspection support.
  • Demonstrated leadership in driving laboratory quality improvement initiatives and strategic quality initiatives
  • Experience influencing cross-functional decisions at the department or site level without direct authority

• Knowledge:
  • Strong knowledge of GMP regulations, including 21 CFR Parts 210/211, 11, and applicable FDA/EMA guidance.
  • Strong understanding of Computer System Validation for analytical systems.
  • Strong knowledge of cGMP requirements, laboratory quality systems, data integrity, and documentation practices.
  • Experience with method qualification and/or validation (analytical and/or microbiological).
  • Familiarity with laboratory instrument qualification/validation and computerized systems validation (CSV/CSA principles).

• Skills:
  • Familiarity with Laboratory Information Management Systems (LIMs), such as Labvantage, Empower, or similar laboratory systems.
  • Strong attention to detail and critical thinking skills.
  • Ability to interpret regulatory requirements and apply them to complex QC processes.
  • Effective cross-functional communication and influence.
  • Excellent written and verbal communication skills.
  • Strong organizational skills and the ability to manage multiple priorities in a fast-paced GMP environment.
  • Commitment to quality culture, compliance, and inspection readiness.

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.