Sr. Specialist Quality Assurance

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Senior Specialist, Quality Assurance provides essential day‑to‑day QA support to the analytical laboratories. This onsite role focuses on the practical execution of core Quality Management System activities—partnering closely with laboratory teams to uphold GMP expectations, ensure compliant documentation practices, and maintain a strong state of operational control. As a key QA resource for CoA approvals, review of OOS and deviation records, and support of change activities, this position strengthens routine quality operations. The Senior Specialist contributes directly to timely, accurate quality deliverables while collaborating with existing SMEs.

Responsibilities

Critical Performance Areas

• Real-Time Laboratory Quality Support: Provide timely QA guidance to laboratory staff during active testing to identify and mitigate non-compliances as they occur.
• Operational Compliance: Conduct routine review of raw data (e.g., electronic laboratory notebooks (ELN), laboratory journals, logbooks, etc.) to ensure contemporaneous documentation and adherence to data integrity standards.
• Risk-Based Decision Making: Interpret information with a focus on quality assessing risk and impact assessments to support daily operations.
• Technical Investigation Leadership: Lead and mentor staff through laboratory investigations, including deviations, Out of Specification (OOS), Out of Trend (OOT), and non-conformances, directly at the benchtop.
• Efficiency and Release: review and approval for Certificate of Analysis (CoA) release process by performing timely secondary reviews of high-volume laboratory documentation.
  
  

Essential Job Functions

• On‑the‑Floor Oversight: Provide routine, real‑time QA support within the laboratory environment to assist cell‑based bioassay, analytical chemistry, molecular biology, and virology teams during daily operations.
• Risk Assessment and Mitigation: Author, review and participate in formal risk assessments to support quality events and operational changes, ensuring that conclusions are supported with adequate information and clear rationale.
• Change Record Management: Coordinate and act in an approver capacity for change controls, ensuring that impact assessments for methods, equipment, and processes are technically sound.
• Document Review: Perform detailed QA review and approval of SOPs and laboratory records.
• Coaching & Training: Act as a subject matter expert to upskill laboratory staff on GMP expectations and internal Sta ndard Operating Procedures (SOPs).
  
  

Requirements

QUALIFICATIONS

• Education: Bachelor’s Degree in a relevant scientific or technical discipline (e.g., Chemistry, Biology, or Life Sciences).
• Experience: 5 years relevant experience in a quality-facing role biotechnology or pharmaceutical GMP testing environment, specifically in a quality-facing role.
• Technical Depth: Proven experience in reviewing and approving complex technical investigations and laboratory non-conformities.
• Change Control Proficiency: Demonstrated ability to manage change records and conduct thorough impact assessments.
• Communication: Exceptional interpersonal skills with the ability to provide firm but constructive feedback to laboratory personnel in a fast-paced environment.
• Regulatory Scope: Familiarity with U.S. GMP requirements (21 CFR) required; exposure to international standards (ICH, ISO) preferred.
  
  

Other Desired Skills/Abilities

• Prior experience with biotech or pharma contract testing, CDMO, or client‑facing GMP environment
• Familiarity with large molecule, cell therapy, or gene therapy testing oversight.
• Experience supporting QA activities in a contract testing or CDMO setting.
• Advanced proficiency with eQMS (e.g., MasterControl) and LIMS systems.
• Expertise in data integrity program expectations and/or audit/inspection readiness.
• Strong organizational skills and the ability to make sound quality decisions independently.
  
  

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

About Us

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards