Technician – QC – IAPI

Role Summary

Technician – QC – IAPI performs accurate and timely testing of routine lab samples in accordance with GMP and safety guidelines. The technician participates in second person verification of analytical data, laboratory investigations, and equipment calibrations and maintenance by executing well-defined protocols. The role identifies opportunities for improvement within the lab and contributes to continuous improvement initiatives. The position supports strong documentation practices in a highly regulated environment.

Responsibilities

• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols; review results to ensure conformity to standards.
• Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
• Recognize deviations from procedures and initiate investigations.
• Verify (SPV) analytical data of other analysts within the lab as required.
• Identify and communicate opportunities for improvement in daily work activities; troubleshoot equipment and methods as needed.
• Train and mentor others within the lab, where applicable.
• Notify management when required by procedures or standards.
• Perform routine equipment qualifications/calibrations or maintenance through execution of well-defined protocols.
• Participate in laboratory investigations.

Qualifications

• Required: Associate degree (2-year college degree) in a science field related to the lab or 5+ years of demonstrated relevant experience in a GMP (analytical chemistry or microbiology) lab.
• Required: Proficiency with computer systems including Microsoft Office products, LIMS, etc.
• Required: Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations.
• Required: Ability to work in a highly regulated environment.
• Required: Demonstrated strong math and documentation skills.
• Required: Demonstrated strong oral and written communication and interpersonal interaction skills.
• Preferred: Associate Degree in Biotechnology; previous experience with deviation and change control processes.
• Preferred: Experience with wet chemistry techniques, HPLC, GC, FT-IR, UV/Vis, AA, KF, TOC, Conductivity, and compendial testing.

Education

• Associate Degree or equivalent.

Additional Requirements

• Primary work schedule will be 40 hours, including Saturday and Sunday, on second shift (3:00pm to 11:30pm).
• Overtime and holiday work will be required to support business needs.
• Must complete applicable Learning Plan for a Technician – QC – IAPI.
• Tasks may require repetitive motion and standing for long periods of time.
• Must be able to lift at least 20 pounds.
• May be required to provide 24 hour coverage.
• Overtime, after business hours or other off-shift work may be required as necessary.