Quality Control Specialist

3 weeks ago

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

Central Admixture Pharmacy Services, Inc. is seeking a highly skilled QC Coordinator - Microbiology to join our team.

As a QC Coordinator - Microbiology, you will be responsible for ensuring site-specific compliance with CAPS Standard Operating Procedures (SOPs). This includes performing and reviewing the Daily Compliance Verification Checklist, documenting results, and reporting to the immediate supervisor.

Key responsibilities include:

  • Performing and/or coordinating completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts.
  • Collecting Environmental Monitoring samples as necessary.
  • Providing new staff training.
  • Performing sterility tests, aseptic technique qualifications, and media fill process validations.
  • Reviewing and verifying batch records, including raw materials, labeling, and product test results.
  • Documenting non-compliance and evaluating if further investigation is needed.
  • Submitting samples to labs for chemical assay and microbial tests.
  • Tracking vendor equipment calibration and maintenance records and assessing for deviations.
  • Entering test results or summaries into the pharmacy-specific monthly and quarterly Quality Assurance report template.
  • Documenting results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions.
  • Supporting internal and external audits.
  • Maintaining quality records, including equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, and clean room certification.

This is a challenging and rewarding role that requires strong attention to detail, excellent communication skills, and the ability to work independently in a fast-paced environment.

Requirements:

  • Bachelor's degree required or equivalent combination of education and experience.
  • Minimum of 2 years of experience in a QC/QA department of a pharmaceutical or Allied Health Science.

Preferred Qualifications:

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

What We Offer:

B. Braun offers a competitive salary, excellent benefits package, and opportunities for professional growth and development.

Join our team and contribute to the success of Central Admixture Pharmacy Services, Inc.

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