Job Description
SUMMARY
Join a mission-driven pharmaceutical team focused on advancing quality in ophthalmic compounding. This on-site position offers hands-on responsibilities in quality control sample management—ranging from raw materials to stability and finished drug products—and involves daily monitoring, documentation, software entry, and analysis. Candidates will have the opportunity to contribute to key regulatory and quality systems, stability studies, and reporting efforts essential to maintaining product integrity and compliance.
RESPONSIBILITIES
- Coordinate and handle QC samples including raw materials, finished drug products, and stability items, ensuring accurate documentation and shipment to testing labs.
- Enter and track sample data, test results, and anticipated QC release timelines in designated software platforms.
- Initiate and monitor stability studies; manage chamber loading, scheduling, and sample pulls.
- Maintain updated inventory in sample management and stability systems, and ensure appropriate storage utilization.
- Compile, transcribe, and analyze CoA results; prepare summaries and regression reports as required.
- Draft and revise protocols and specifications for stability and finished product evaluations.
- Support annual product quality reviews (APQRs) with relevant stability data and analytics.
- Order, log, and oversee reagent and supply inventory for lab use, ensuring readiness and regulatory compliance.
- Follow up with laboratories to obtain timely testing results and update tracking documentation accordingly.
- Collaborate with quality and QC teams on additional tasks as needed to maintain operational flow and compliance.
QUALIFICATIONS
- Bachelor’s degree in a scientific discipline preferred.
- Minimum 5 years of experience in a pharmaceutical laboratory setting, or an equivalent combination of education and experience.
- Proficiency with data entry, spreadsheets, and database systems.
- Strong organizational skills and attention to detail.
- Ability to manage multiple concurrent tasks effectively.
- Positive and collaborative team-oriented mindset.
- Strong communication skills, both verbal and written.
- Ability to work 40 hours per week on-site, with occasional additional hours as needed.
- Comfort working in a cleanroom environment requiring PPE and adherence to hygiene protocols (e.g., no makeup or jewelry).
- Capability to occasionally lift and move materials up to 25 lbs.
COMPENSATION :$25-$27/hr.
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