About the Role
Ensure that materials for compliance meet standards and requirements, and that tests are completed in accordance with established standard operating procedures (SOP). This role includes responsibilities such as monitoring the BCL stability program and performing testing as required, as well as overseeing chemical stocks used in analysis and informing the lab supervisor of required chemicals.
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Job Accountabilities & Activities
- Prepare/sample and test materials from all phases of manufacturing or other handling processes to determine compliance with standards and requirements.
- Document and create technical reports for tests performed and any adverse events.
- Conduct tests according to approved testing procedures.
- Perform instrument troubleshooting, calibration, and repair as necessary.
- Effectively handle QC instruments and troubleshoot when necessary.
- Support local and external audit programs.
- Ensure successful completion of internal and external audits without major observations related to human factors.
- Collaborate on qualification protocols and the preparation of SOPs, along with associated procedure changes.
- Adhere to good documentation practices.
- Assist the supervisor in out of limit (OOL) investigations and ensure their completion.
- Conduct inventory checks and requests for lab reagents and consumables.
Education & Certifications
- Bachelor’s degree in Chemistry, Chemical Engineering, or equivalent.
Required Years of Experience
- Two years or more of relevant experience in pharmaceuticals or related industries.
