Quality Control Coordinator - Process Control
CAPS, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nations largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.
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 Pharmacys 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
- B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
- Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science.
- As assigned by Supervisor.
- Minimum of 2 years experience in pharmacy preparation.
- Pharmacy Technician Certification.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
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.
Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
- Some travel may be required.
- Ability to stand and/or sit for long periods of time.
- Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.
- Ability to lift up to 20 lbs.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Equal Opportunity Employer Veterans/Disabled