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CAPS QC Coordinator-Microbiology

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B. Braun Medical Inc. (US)

2mo ago

  • Job
    Full-time
    Junior Level
  • Science
    Healthcare
  • Allentown

AI generated summary

  • You need a bachelor’s degree, 2 years in QC for pharma/allied health and pharmacy prep, plus a Pharmacy Technician Certification.
  • You will ensure compliance with SOPs, monitor environmental conditions, train staff, review documents, verify batch records, track equipment, support audits, and maintain quality documentation.

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

Responsibilities

  • Ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs).
  • 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 Pharmacy’s staff meetings
  • As assigned by immediate supervisor.

FAQs

What is the main role of the CAPS QC Coordinator-Microbiology?

The primary role is to ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs) and oversee quality control processes in microbiology.

What are the essential duties of this position?

Essential duties include performing daily compliance checks, environmental monitoring, staff training, document review, sterility tests, and supporting internal and external audits.

What qualifications are required for this job?

A Bachelor’s degree or equivalent education and a minimum of 2 years of experience in a QC department of a pharmaceutical or Allied Health Science are required.

Is previous experience in pharmacy preparation beneficial for this role?

Yes, a minimum of 2 years of experience in pharmacy preparation is desired.

Are there any specific certifications required for this position?

Pharmacy Technician Certification is desired but not required.

What physical demands are associated with this job?

The job requires the ability to sit or stand for long periods, reach, grasp, stoop, pull, perform repetitive motions, and lift up to 20 pounds.

What type of work environment will I be in?

You will work indoors in a cleanroom environment, wearing protective cleanroom attire, in controlled temperatures, and may encounter loud noise.

Does the position require travel?

Some travel may be required for this role.

What benefits does B. Braun offer for this position?

B. Braun offers an excellent benefits package including healthcare, a 401(k) plan, and tuition reimbursement.

What is the pay range for this role?

The targeted pay range for this position is $22.76 to $28.45, depending on factors such as skill sets, experience, and other related considerations.

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B. Braun Medical Inc. (US)

Science & Healthcare
Industry
10,001+
Employees
1839
Founded Year

Mission & Purpose

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, PA and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit bbraunusa.com.

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