Laboratory Quality Specialist

Job Description

Job Description

Job Summary:

The Laboratory Quality Specialist is responsible for maintaining and continuously improving the laboratory Quality Management System (QMS) in support of regulatory compliance, data integrity, product quality, laboratory impartiality, and patient safety within a regulated pharmaceutical laboratory environment. This role provides quality oversight for laboratory operations, testing support systems, documentation, investigations, audits, supplier and equipment quality activities, COA release, and inspection readiness.

This position works closely with the Laboratory Manager to support laboratory quality priorities, coordinate quality system activities, communicate compliance expectations, and help ensure laboratory operations remain aligned with regulatory requirements, internal procedures, continuous improvement goals, and the impartiality of the laboratory from manufacturing operations. The role requires strong knowledge of cGMP, GLP, applicable USP expectations, FDA-regulated laboratory practices, quality systems, risk management, and effective cross-functional collaboration.

Responsibilities: 

Quality Management System Support & Governance

• Maintain and improve the laboratory QMS to ensure alignment with cGMP, GLP, applicable USP chapters, regulatory expectations, internal quality standards, and laboratory impartiality requirements.
• Review and approve laboratory quality policies, SOPs, forms, logs, quality plans, and work instructions.
• Maintain quality system processes for deviation management, CAPA, change control, risk management, document control, training, supplier qualification, audit readiness, management review, and objective quality decision-making independent from manufacturing pressure or conflicts of interest.
• Define, monitor, trend, and report laboratory quality metrics to identify compliance risks, impartiality risks, recurring issues, and continuous improvement opportunities.
• Partner with laboratory leadership and cross-functional stakeholders to ensure the QMS supports reliable testing, defensible data, timely investigations, compliant decisions, and quality system gap remediation.
• Other duties as assigned.

Regulatory Compliance, Documentation, Data Integrity & Continuous Improvement

• Oversee quality aspects of laboratory equipment qualification, calibration, maintenance, cleaning, environmental controls, temperature monitoring, and computerized or electronic laboratory systems.
• Review and approve method implementation, transfer, verification, validation, and lifecycle maintenance from a quality and regulatory perspective.
• Support regulatory inspections, client audits and internal audits.
• Perform deviation investigations, CAPA, OOS/OOT investigations, change control, training qualifications, and COA review/release.
• Review laboratory trends, deviations, complaints, audit findings, analytical report accuracy, and process performance to identify systemic issues and recommend preventive actions.
• Contribute to monthly and quarterly quality metrics reporting, including trend analysis, risk escalation, and action tracking.
• Lead or participate in continuous improvement projects that strengthen laboratory compliance, quality processes, efficiency, documentation, and operational reliability.
• Support supplier assessment and qualification activities for laboratory materials, services, contract testing laboratories, calibration providers, and critical vendors.

Required Skills/Abilities: 

• Strong working knowledge of GxP, including cGMP, GLP, FDA-regulated laboratory expectations, applicable USP requirements, and pharmaceutical quality systems.
• Demonstrated ability to maintain and improve laboratory QMS, including document control, training, deviations, CAPA, change control, audits, supplier quality, management review, data integrity, and impartiality controls.
• Excellent written and verbal communication skills, including technical writing, investigation documentation, root cause analysis, and client or auditor communication.
• Ability to confidently interact with clients, auditors, laboratory staff, manufacturing partners, leadership, and internal stakeholders while supporting independent, objective quality decisions.
• High attention to detail with strong judgment, integrity, confidentiality, and commitment to data integrity, patient safety, and laboratory impartiality.
• Ability to interpret regulatory requirements and translate them into practical procedures, training, controls, and quality decisions.
• Proficiency with Microsoft Office, including Excel, Word, and PowerPoint; experience with quality management systems, LIMS, electronic document management systems, and data trending tools preferred.

Education and Experience:

• Bachelor’s degree in Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, Medical Laboratory Science, or a related scientific discipline required; advanced degree preferred.
• Minimum of 4 years of QA /QC experience within a pharmaceutical or regulated laboratory environment required.
• Experience supporting regulatory inspections, client audits, internal audits, deviation investigations, CAPA, OOS/OOT investigations, change control, training systems, analytical report and COA review/release, and QMS implementation preferred.
• ASQ, RAC, ISO 9001, ISO 17025, Lean Six Sigma, or related quality/regulatory certification preferred but not required.

Physical Requirements: 

• Ability to stand for extended periods while performing laboratory procedures.
• Ability to lift up to 25 lbs. (media, solvent containers, equipment parts).
• Work performed in controlled laboratory environments.
• Position may require occasional weekend, holiday, or off-shift work depending on laboratory needs.

Benefits:

• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.