Quality Control Coordinator/Process Control Job-B. Braun Group

Location: AZ-Phoenix, USA           

Company: B. Braun Group

Job Position: Quality Control Coordinator/Process Control

JOB DESCRIPTION:

Qualification:

Education & Experience

1. B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)

2. Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science.
3. As assigned by Supervisor.
4. Minimum of 2 years experience in pharmacy preparation.
5. Pharmacy Technician Certification.
6. Knowledge of pharmacy operations and regulatory guidelines.
7. Ability to perform pharmacy calculations. 
8. Responsibilities: Other Duties
9. As assigned by immediate supervisor.

Job Responsibility:

1. Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.

2. Perform and/or coordinate completion of:
3. Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts
4. Collect Environmental Monitoring samples as necessary
5. New staff training
6. Sterility tests, aseptic technique qualifications, and media fill process validations.
7. Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:
8. Verify that raw materials meet specification limits
9. Verify accuracy of labeling
10. Perform final disposition of Batch
11. Verify that product test results meet specification limits
12. Verify that all documentation is complete
13. Document non-compliance and evaluate if further investigation is needed
14. Submit samples to the appropriate labs for chemical assay and microbial tests.
15. Track vendor equipment calibration and maintenance records and assess for deviations.
16. Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template.
17. Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
18. Support Internal & External audits.
19. Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
20. Participate in Director of Pharmacy’s staff meetings