QC Coordinator-Process Control Specialist

4 weeks ago

Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time
Central Admixture Pharmacy Services, Inc.

CAPS QC Coordinator-Process Control

Job Summary:

Central Admixture Pharmacy Services, Inc. is seeking a highly skilled QC Coordinator-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 CAPS Standard Operating Procedures (SOPs).

Key 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.
  • New staff training.
  • Sterility tests, aseptic technique qualifications, and media fill process validations.
  • Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records.
  • Verify that raw materials meet specification limits.
  • Verify accuracy of labeling.
  • Perform final disposition of Batch.
  • Verify that product test results meet specification limits.
  • Verify that all documentation is complete.
  • 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.
  • Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions.
  • Support Internal & External audits.
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
  • 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.


Preferred Qualifications:

  • Minimum of 2 years experience in pharmacy preparation.
  • Pharmacy Technician Certification.


Physical Demands:

  • Some travel may be required.
  • Ability to stand and/or sit for long periods of time.
  • Ability to reach, grasp, stoop, pull and perform repetitive motion procedures.
  • Ability to lift up to 20 lbs.


Work Environment:

  • Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.


What We Offer:

B. Braun offers an excellent benefits package, which includes 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

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Equal Opportunity Employer Veterans/Disabled

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.

Compensation details: 28.45 Hourly Wage

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