Senior Quality Control Specialist
6 hours ago
Central Admixture Pharmacy Services, Inc. is seeking a highly skilled Senior Quality Control Specialist - Process Control to join our team. As a key member of our quality assurance team, you will be responsible for ensuring site-specific compliance with our Standard Operating Procedures (SOPs).
Responsibilities
- Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.
- Perform and/or coordinate completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts.
- Collect Environmental Monitoring samples as necessary.
- Conduct new staff training.
- Perform sterility tests, aseptic technique qualifications, and media fill process validations.
- Review and verify batch records, including raw materials, labeling, and product test results.
- Document non-compliance and evaluate if further investigation is needed.
- Submit samples to the appropriate labs for chemical assay and microbial tests.
- Track vendor equipment calibration and maintenance records and assess for deviations.
- Enter test results or summaries into the pharmacy-specific monthly and quarterly Quality Assurance report template.
- Document results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions.
- Support internal and 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.
Requirements
- Bachelor's degree required or equivalent combination of education and experience.
- Minimum of 2 years experience in a QC/QA department of a pharmaceutical or Allied Health Science.
What We Offer
B. Braun offers an excellent benefits package, including healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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