Quality Technician

Job Title: Quality Technician / QA Process Quality InspectorJob Description

The Quality Technician / QA Process Quality Inspector works primarily on the production floor to ensure strict adherence to cGMP standards and quality procedures in a pharmaceutical or biotechnology manufacturing environment. This role partners closely with production operators, supervisors, and leads to monitor compliance, support real-time investigations and CAPA activities, and ensure documentation is accurate, complete, and audit-ready. The position offers the opportunity to contribute in a smaller company setting where individual impact is visible, with strong benefits, career growth options within QA, and a supportive team environment.

Responsibilities

• Spend the majority of the workday (approximately 80%) on the production floor monitoring processes, equipment, and personnel for compliance with cGMP and internal quality procedures.

• Collaborate daily with production operators, production supervisors, and production leads to ensure everyone follows current Good Manufacturing Practices (cGMPs) and established standard operating procedures.

• Participate in shift transfer activities with the first-shift Process Quality Inspector to communicate events, issues, and key information from the prior shift.

• Meet with the production supervisor before the shift starts to review any required corrections, documentation updates, or quality-related tasks that need to be completed.

• Conduct routine walk-throughs of each unit or suite to observe operations, verify compliance, and provide on-the-spot support to production operators while minimizing disruption to their work.

• Perform additional walk-around inspections approximately one hour after initial checks to confirm ongoing compliance and to follow up on any previously identified issues.

• Review and complete required quality documentation, ensuring that forms and records are accurate, legible, and compliant with documentation standards.

• Verify that all clean-down activities are properly completed, including checking cleanliness of suites, equipment, and parts, conducting inspections, and signing off on clean-down records.

• Inspect all parts and equipment in the suite as needed, ensuring they meet cleanliness and readiness requirements prior to use.

• Work with document reviewers and production supervisors to correct paperwork issues, including adding appropriate footnotes and ensuring there are no blanks, write-overs, or documentation errors.

• Perform real-time corrections and provide training related to incidents and deviations, ensuring that corrective actions are documented and implemented effectively.

• Assist in developing or delivering training related to incidents, deviations, or new procedures, working in partnership with production supervisors to ensure understanding and compliance.

• Support sampling activities as a backup function for QA, following established sampling plans and procedures.

• Perform labeling tasks as a backup function, including printing and verifying approval labels for raw materials that have been approved or retested for use in production.

• Conduct investigations as part of the QA function, gathering data, documenting findings, and contributing to root cause analysis and CAPA implementation.

• Participate in CAPA-related work, ensuring that corrective and preventive actions are implemented, monitored, and documented according to quality system requirements.

• Demonstrate initiative by proactively identifying potential quality issues on the production floor and escalating or addressing them appropriately.

• Collaborate with the QA team and production leadership to resolve issues, exercise appropriate authority when needed, and ensure consistent application of quality standards.

• Model reliability and accountability by managing multiple tasks, meeting deadlines, and consistently demonstrating the importance of punctuality and responsibility.

Essential Skills

• 13+ years of experience in a cGMP pharmaceutical, biotechnology, food, or dietary supplement manufacturing environment.

• 13+ years of quality, QA, or auditing experience, with at least 1 year as a minimum requirement.

• 13+ years of production floor experience in a regulated manufacturing setting.

• Demonstrated knowledge of cGMP and GMP principles and their application in a production environment.

• Experience working in pharmaceutical or biotechnology manufacturing environments, including familiarity with iso standards such as ISO 9001.

• Bachelors degree in a Life Sciences discipline (such as biology, ch