Job Summary
We are seeking a dedicated and detail-oriented individual to join our pharmaceutical manufacturing team. The successful candidate will perform and review analysis of in-process, release, and stability samples of API and/or filled product in accordance with cGMP, site, and corporate policies and procedures. The role requires maintaining testing proficiency, ensuring compliance with GMP and environmental standards, and providing operational support to the QC Laboratory.
Essential Functions
- Ensure accuracy and scientific soundness of lab data.
- Ensure environmental compliance.
- Ensure GMP compliance of the laboratory.
- Maintain testing proficiency for methods.
- Ensure timeliness of lab results and investigations.
- Provide operational support to the QC Laboratory.
- Support the DAPI US & DFP water testing program.
- Support the Lab Preventative Maintenance program.
- Perform other accountabilities, as assigned.
Physical Requirements
- Move equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
- Ability to do close precision work with hands.
- Must be able to remain in a stationary position (sitting and standing) 50% of the time.
- May require corrected vision to 20/25 based on role.
- May require color vision based on role.
- Occasionally ascends/descends a ladder.
- May be required to work at elevated heights.
- Occasionally works around odorous and/or hazardous materials.
Job Requirements
- Associate's degree in a scientific field or equivalent combination of education and relevant experience preferred.
- Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory a plus.
- Able to perform routine testing per SOP and GMP standards a plus.
- Knowledgeable in basic laboratory techniques a plus.
- Must demonstrate attention to detail preferred.
- Strong communication skills (verbal and written) a plus.
- Ability to execute testing according to a structured plan a plus.
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