Qc Coordinator - Caps

Position Summary:

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

Responsibilities: Essential Duties

• Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
• Perform and/or coordinate completion of:
• Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts
• Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:
• Sterility tests, aseptic technique qualifications, and media fill process validations.
• 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.
• Document non-compliance and evaluate if further investigation is needed
• Participate in Director of Pharmacy’s staff meetings
• Verify that all documentation is complete
• Verify that product test results meet specification limits
• New staff training
• Verify that raw materials meet specification limits
• Collect Environmental Monitoring samples as necessary
• Verify accuracy of labeling
• Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.
• Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
• Submit samples to the appropriate labs for chemical assay and microbial tests.
• Perform final disposition of Batch
• Support Internal & External audits.

Expertise: Knowledge & Skills

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

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science.
• B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
• As assigned by Supervisor.

Desired:

• 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.

Physical Demands:

• Some travel may be required.
• Ability to stand and/or sit for long periods of time.
• Ability to lift up to 20 lbs.
• Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.

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.

Work Environment:

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.