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Pharmaceutical Quality Control Specialist
1 month ago
Central Admixture Pharmacy Services, Inc. is seeking a highly skilled Pharmaceutical Quality Control Specialist to join our team.
About UsWe are the nation's largest network of outsourcing admixture pharmacies, delivering high-quality same-day admixture services and solutions to hospitals and outpatient facilities for over 28 years. As part of the B. Braun Group of Companies in the U.S., we offer industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities.
The RoleThis is a challenging opportunity for a detail-oriented professional to work in a cleanroom environment, ensuring site-specific compliance with CAPS Standard Operating Procedures (SOPs). The successful candidate will be responsible for performing daily compliance verification checks, reviewing environmental monitoring results, and coordinating completion of essential duties.
Responsibilities- Perform and review Daily Compliance Verification Checklist, document results, and report to supervisor.
- Coordinate completion of environmental monitoring, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts.
- Collect Environmental Monitoring samples as necessary.
- New staff training.
- Sterility tests, aseptic technique qualifications, and media fill process validations.
- Review batch records, verify raw materials meet specification limits, accuracy of labeling, final disposition of Batch, product test results meet specification limits, and documentation completeness.
- Document non-compliance, evaluate if further investigation needed, and submit samples to labs for chemical assay and microbial tests.
- Track vendor equipment calibration and maintenance records, assess deviations, and enter test results into quality assurance reports.
- Document deviation and complaint investigations, causal analysis, corrective actions, and preventive actions under supervisor direction.
- Support internal & external audits.
- Maintain quality records, including equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, and clean room certification.
- Participate in Director of Pharmacy staff meetings.
- Bachelor's degree or equivalent combination of education and experience required.
- Minimum 2 years experience in QC department of pharmaceutical or Allied Health Science.
- Desirable: Minimum 2 years experience in pharmacy preparation, Pharmacy Technician Certification.
A competitive estimated salary range of $22.76 - $28.45 per hour is offered for this role.
What We OfferB. Braun offers an excellent benefits package, including healthcare, 401(k) plan, and tuition reimbursement. Join a company that promotes best practices for continuous improvement of healthcare products and services.
