Job Description
Job Description
About the Role
We are seeking a hands-on Quality Assurance Lead to take ownership of quality systems and execution across our manufacturing operation. This role works directly with the Director of Quality and serves as an extension of quality leadership on the production floor and in documentation systems.
This is a highly practical, execution-focused role—ideal for someone who enjoys being involved in operations, ensuring things are done correctly, and keeping systems organized and audit-ready.
Duties:
Production Floor Quality Oversight
- Verify correct raw materials, components, and lot numbers are used
- Confirm accurate weighing and dispensing of ingredients
- Perform line clearance and in-process checks
- Monitor fill weights, lot coding, and packaging accuracy
- Enforce GMP standards (hair nets, gloves, hygiene, behavior)
- Address issues in real time and escalate when needed
Batch Records & Documentation
- Prepare and manage batch record packets
- Ensure records are completed accurately and in real time (GDP / ALCOA+)
- Review batch records for completeness, accuracy, and consistency
- Organize and maintain audit-ready documentation
Materials & Receiving Support
- Assist with incoming raw material and component verification
- Review COAs and specifications
- Ensure proper quarantine and release status
- FIFO processing
Investigations & CAPA Support
- Gather documentation and support deviations and investigations
- Draft initial summaries and track CAPA progress
- Work with the Director of Quality on final review and closure
Training & SOPs
- Coordinate and track GMP/GDP training
- Maintain training matrix and records
- Draft and update SOPs and quality documents
- Ensure only current, approved documents are in use
Quality Systems Support
- Perform routine internal checks and audits
- Help identify gaps and improve systems
- Maintain logs (batch, training, calibration oversight, etc.)
Qualifications
Required:
- 2–5+ years experience in QA/QC within a regulated manufacturing environment (FDA, food, or similar)
- Strong understanding of:
-
- GMP practices
- Good Documentation Practices (GDP / ALCOA+)
- Highly organized with strong attention to detail
- Comfortable working on the production floor daily
- Able to speak up and enforce standards when needed
Preferred:
- Experience in OTC, pharmaceutical, cosmetic, or food manufacturing
- Familiarity with batch records, SOPs, inventory management systems
- Experience supporting investigations or CAPAs
Company DescriptionJoin a family-run business, established in 1989, where your role isn’t fixed — you help define it, and your future. We value initiative, teamwork, and reward those who step up and lend a hand.
Company Description
Join a family-run business, established in 1989, where your role isn’t fixed — you help define it, and your future. We value initiative, teamwork, and reward those who step up and lend a hand.