About the Role
The Quality Control Technician is responsible for the real-time monitoring, sampling, and physical testing of raw materials, in-process components, packaging assets, and finished products at The Wellness Factory. Operating directly on the production floor (Zone 3) and within the receiving dock, this role ensures that all materials and manufacturing activities conform to strict cGMP (21 CFR 111) regulations and internal quality specifications.
Core Responsibilities
- Active Line Auditing: Perform routine, scheduled audits of the production lines, monitoring encapsulation fill weights, and batch-processing parameters to verify execution against the Master Production Record (MPR).
- Weighing & Dispensing Oversight: Inspect and verify raw material dispensing activities, ensuring that balance calibrations are verified and that operators are utilizing correct lot numbers and ingredient quantities.
- Line Clearance Verification: Perform visual and technical inspections of manufacturing suites and processing equipment to verify successful line clearance before production begins.
Sampling & Material Verification
- Technical Sampling: Collect raw material, in-process, and finished product samples for internal retention, stability tracking, or shipment to third-party testing laboratories.
- Retain Management: Maintain, catalog, and secure the facility retention sample inventory in appropriate environmental conditions.
- Documentation Review: Inspect incoming Certificates of Analysis (CoA) from raw material suppliers to verify that chemical, heavy metal, and microbiological traits match internal raw material specifications.
Data Integrity & Record Keeping
- Real-Time Logging: Maintain meticulous, contemporaneous records of all inspections, weight checks, and physical testing results within the active Batch Production Record (BPR) in compliance with ALCOA+ Good Documentation Practices (GDP).
- Defect Escalation: Immediately document and report any material defects, processing variances, or potential contamination events to the Quality Director and Production Supervisor.
Key Performance Indicators (KPIs)
The success of the Quality Control Technician will be measured by the following operational metrics:
- Sampling Accuracy Rate (100%): Executing sample collection, cross-contamination prevention, and chain-of-custody documentation perfectly with zero lot mix-ups.
- Audit Inspection Completion: Executing 100% of required in-process line checks and weight-verification intervals during active production shifts.
- Documentation Right-First-Time: Ensuring all QC logs, test results, and BPR sign-offs are completed clearly, accurately, and without omissions.
- Response Efficiency: Promptly reporting and documenting out-of-specification (OOS) floor events to minimize production downtime and material waste.
Qualifications
Education & Experience
- Education: Associate’s degree in a technical or scientific discipline (e.g., Chemistry, Biology, Food Science, or Engineering); or equivalent professional laboratory/manufacturing quality experience.
- Experience: 2+ years of hands-on quality control or quality assurance experience inside a regulated cGMP manufacturing environment (Dietary Supplements, Pharmaceuticals, Cosmetics, or Food Processing).
- Regulations: Strong understanding of Good Manufacturing Practices (GMP), specifically 21 CFR 111.
- Physical Requirements: Ability to lift up to 50 lbs and remain on your feet/walking for the duration of your shift.
- Mindset: Ability to work independently with minimal supervision, think critically, and communicate effectively with the production team.
Technical Competencies & Skills
- cGMP Regulations: Strong working knowledge of foundational cGMP rules, cleanroom protocols, and material status designations (Quarantine vs. Released).
- Testing Methods: Familiarity with basic analytical testing concepts, physical testing equipment (e.g., automated balances, calipers, vernier micrometers, tap density testers), and third-party laboratory coordination.
- Analytical Aptitude: Ability to read, interpret, and cross-reference intricate technical documentation, raw material spec sheets, and material safety data sheets (SDS).
Physical Demands & Environment
- Stamina: Ability to maintain peak alertness while walking, standing, and actively auditing the manufacturing suites for 6+ hours of an operational workday.
- Strength: Ability to occasionally lift and maneuver material containers or sample boxes weighing up to 50 lbs.
- Cleanroom Compliance: Comfort working within an active processing environment, requiring strict adherence to full cleanroom garbing protocols (gowns, hairnets, beard covers, safety glasses, and gloves) for long intervals.
Schedule: Monday – Thursday, 2:00 PM – 7:00 PM
(Occasional Fridays with advance notice; occasional morning coverage for vacations starting at 8:00 AM)
Pay: $18.00 - $20.00 per hour
Benefits:
Work Location: In person
