Quality Assurance Specialist - 1st Shift

Lynchburg, VA

Full Time

Entry Level

Quality Assurance Specialist I – 1st Shift

DEPARTMENT: Quality

OCCUPATIONAL SUMMARY:
We are seeking a high-caliber QMS Specialist to manage the lifecycle of quality events. The QA Specialist will be responsible for investigating customer complaints, processing deviations, and overseeing the change control system to ensure that all modifications to processes or products are handled without compromising quality or regulatory standing.
ROLES AND RESPONSIBILITIES:

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

QUALIFICATIONS:

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.

ACCOUNTABILITY:
Senior Manager, Quality Assurance

WHAT WE OFFER
Here at Fleet, you can have a good job that can grow into a great career.

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.

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over

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Quality Assurance Specialist - 1st Shift

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