Quality Assurance Specialist - 1st Shift

• Complaint Management: Process and investigate product quality complaints; perform root cause analysis (RCA) and coordinate with medical or technical teams to assess patient/user risk.
• Deviation Handling: Lead the investigation of non-conformances or deviations from approved procedures; categorize severity (Minor/Major/Critical) and ensure timely closure.
• Change Control Oversight: Act as a subject matter expert for the Change Control Board; review proposed changes to equipment, methods, or documentation to ensure they are justified and validated.
• CAPA Integration: Ensure that complaints and deviations trigger Corrective and Preventive Actions (CAPA) when systemic issues are identified and verify the effectiveness of these actions.
• Quality Metrics: Develop and present dashboards and KPIs tracking the status and aging of open complaints, deviations, and changes for Management Review.
• Technical Writing: Author and review complex investigation reports and Standard Operating Procedures (SOPs) to ensure clarity, brevity, and audit-readiness.
• Audit Support: Participate in facility’s Internal Audit program, including auditing, recording observations, work order audits, assigning corrective actions, tracking progress, and report writing.
• Prepare annual schedules, reports, policies, procedures, work instructions, and review data
• Participate in Inspection Readiness activities and support audits and Regulatory Inspections. Demonstrate strong verbal and written communication skills during inspections/audits.
• Peer review of procedures, data, and reports for accuracy, completeness, and conformance to SOPs.
• Provides monthly reports on time for key performance indicators and Quality governance meetings.
• Interacts with all departments, including, but not limited to Operations, Maintenance, Distribution, Quality Control, Medical Affairs, Supply Chain and Product Development.
• Support continuous improvement projects.
• Other duties as assigned

• Education: BS plus 2 yrs experience in a GMP environment, or AS with 4 years’ experience in a GMP environment, or if no degree, then 6 years’ experience in a GMP environment.
• Problem-Solving: Proficiency in root cause analysis tools such as the 5 Whys, Fishbone Diagrams, and FMEA.
• Software Proficiency: Experience with QMS software/Electronic Document Management Systems (e.g., MasterControl, EtQ Reliance, or TrackWise).
• Soft Skills: Strong interpersonal and communication skills to influence cross-functional teams without direct authority.
• Technical Writing: Proven ability to write clear, concise, and evidence-based investigation reports.

• The start of a great career working with a diverse group of great people
• The health and safety of every employee... our top priority
• A clean, air-conditioned cGMP environment
• Top notch benefits –paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.
• Stability – a record of strong financial performance and part of a growing $1billion company
• A business supporting the Lynchburg community for over 150 years.

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