Quality Technician / QA Process Quality InspectorJob

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.

Auditing Chemistry Visionary Operations Leadership Innovation Notetaking Reliability Punctuality Cleanliness Biochemistry Microbiology Communication Life Sciences Investigation Biotechnology Accountability Pharmaceuticals ISO 9000 Series Safety Assurance ISO/IEC Standards Root Cause Analysis Dietary Supplements Time Off Management Organizational Skills Packaging And Labeling Ability To Meet Deadlines Quality Management Systems Program Process Monitoring Engineering Design Process Good Manufacturing Practices Corrective And Preventive Action (CAPA) Current Good Manufacturing Practices (cGMPS), * 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 investigations and CAPA activities.
• Ability to communicate clearly and effectively with production operators, supervisors, and QA colleagues across shifts.
• Strong organizational skills with the ability to handle multiple tasks and responsibilities in a dynamic production environment.
• Demonstrated reliability, responsibility, and understanding of the importance of punctuality in a manufacturing setting.

Additional Skills & Qualifications

• Experience as a production operator, production technician, or in a similar hands-on manufacturing role.
• Background in laboratory work or related environments involving biology, chemistry, biochemistry, or microbiology.
• Familiarity with ISO standards, including ISO 9001, in a quality or manufacturing context.
• Bilingual communication skills are ideal but not mandatory.
• Experience in roles with lead or assistant responsibilities, particularly where handling issues and exercising authority were required.
• Ability to remain composed and effective when managing a high volume of tasks or issues on the production floor.
• Demonstrated initiative in identifying and resolving problems, including explaining how issues were handled in previous roles.
• Interest in career growth within QA, including potential future opportunities in office-based QA roles or QC review and batch approval., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

This is a full-time role within a small QA team of fewer than ten people in a cGMP-regulated pharmaceutical or biotechnology manufacturing facility. The position is heavily floor-based, with approximately 80% of the time spent in production suites and units and about 20% focused on documentation and paperwork. You will work closely with production staff across multiple shifts, including overlapping coverage with other Process Quality Inspectors to ensure continuous quality oversight. Overtime is currently limited and not heavily expected, and the team structure is designed so that three PQIs can provide overlapping hours and support. The environment emphasizes close collaboration, where you are known as an individual rather than a number, and offers strong benefits, including a highly competitive benefits package and a robust paid time off program. Full-time employees accrue up to 17 days (136 hours) of PTO in their first year, increasing to 22 days (176 hours) after the first 12 months, with PTO rolling over year to year and usable as soon as it is accrued, subject to supervisor approval. The culture supports professional growth within QA, including opportunities to move into office-based QA roles or QC review and batch approval responsibilities over time. Job Type & Location

This is a Contract to Hire position based out of Verona, WI. Pay and Benefits

The pay range for this position is $21.00 - $28.00/hr.

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