QC Coordinator-Chemistry Specialist

4 weeks ago

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

CAPS QC Coordinator-Chemistry

Our company, Central Admixture Pharmacy Services, Inc., is seeking a highly skilled CAPS QC Coordinator-Chemistry to join our team. This role is responsible for ensuring site-specific compliance with our Standard Operating Procedures (SOPs).

Responsibilities

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 e.g. 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.
  • Perform 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 Pharmacys staff meetings

Requirements:

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

We offer a competitive salary and benefits package, including healthcare, a 401(k) plan, and tuition reimbursement. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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