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, chemistry, biochemistry, microbiology, or a related field).

Ability to review and verify documentation for completeness, accuracy, and compliance, including identifying and correcting documentation errors.

Experience supporting or conducting quality investigatio