Primary Responsibilities:

Quality Control & Testing

• Inspect and release incoming materials, WIP, and finished goods.
• Support validations and testing (DQ/IQ/OQ/PQ).
• Test obsolete, off-spec, or rejected materials and provide recommendations to Quality Manager.
• Approve daily batch release reports and escalate failures immediately.

Quality Data & Documentation

• Enter, verify, and audit QA data; ensure accuracy of all results and reports.
• Manage quality documentation (procedures, work instructions, forms, version control).
• Support training on quality procedures and standards.

Audits, CAPA & Compliance

• Support internal, external, and customer audits.
• Track nonconformities and assist with corrective/preventive actions (CAPA).
• Communicate critical QA issues, equipment concerns, and deviations promptly.

Leadership & Continuous Improvement

• Train and mentor Level I–III technicians; support onboarding.
• Participate in Quality, Safety, Housekeeping, and Waste Minimization meetings.
• Contribute to continuous improvement initiatives and plant support activities.

Safety & Housekeeping

• Follow all EHS requirements, maintain proper PPE usage, and ensure good housekeeping practices.

Minimum Requirements

• High School diploma or GED plus a 2-year technical program or AA degree in chemistry, biochemistry, or related field.
• 5–7 years as Lab Technician III or equivalent experience.
• Strong knowledge of quality systems (ISO 9001 or similar) and documentation control.
• Effective written and verbal communication skills.
• Strong analytical, problem-solving, and collaboration abilities.
• Proficiency in Microsoft Office and laboratory information systems.
• Experience in a controlled lab or regulated manufacturing environment.

Preferred Requirements

• Experience with Lean, Six Sigma, RCA, or 5S.
• SAP experience (QM/MM preferred).
• Experience leading small projects or trials.
• Prior mentoring or training experience.
• Strong data analysis skills.
  
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