CAPS QC Coordinator-Microbiology

Society for Conservation Biology; Wescosville (PA); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control professional to ensure compliance with standard operating procedures in a cleanroom environment. This role involves conducting environmental monitoring, performing sterility tests, and maintaining quality records to support pharmaceutical operations. The ideal candidate will possess a Bachelor's degree and have at least two years of experience in a quality control setting. Join a team that values safety and quality in healthcare, and enjoy a comprehensive benefits package while contributing to impactful work in the pharmaceutical field.

Benefits

Healthcare benefits

401(k) plan

Tuition reimbursement

Qualifications

• Minimum 2 years experience in a QC department of pharmaceutical or Allied Health Science.
• Pharmacy Technician Certification is desired.

Responsibilities

• Perform Daily Compliance Verification and document results.
• Conduct environmental monitoring and sterility tests.

Skills

Pharmacy operations knowledge

Pharmacy calculations

Education

Bachelor's degree

Equivalent combination of education and experience

Tools

Quality Assurance documentation

Job description

View more categories View less categories Sector Consultancy/Private Sector Field Conservation science Discipline Biology Salary Type Salary Employment Type Full time

Company: Central Admixture Pharmacy
Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States
Functional Area: Other Areas
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4027

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 compounding, ostomy and wound care, 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.

Position Summary:

Ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs).

Responsibilities: Essential Duties

• 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

Expertise: Knowledge & Skills

• Knowledge of pharmacy operations and regulatory guidelines.
• Ability to perform pharmacy calculations.
• Responsibilities: Other Duties
• As assigned by immediate supervisor.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• 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.

Desired:

• 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.

Target Based Range:

$22.76-$28.45

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 www.bbraunusa.com.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic.