CAPS is the nation's largest network of outsourcing admixture pharmacies. A pioneer in the outsourcing of CSPs, CAPS was founded in 1991, and delivers high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities across the nation. CAPS has three 503B Outsourcing Facilities that are registered with the FDA to provide anticipatory compounding services. CAPS also has 22 state licensed 503A regional pharmacies that dispense labeled, patient-specific prescriptions. To learn more, visit www.capspharmacy.com.
Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.
Responsibilities: Essential Duties
- Perform product inspection for defects, leaks and particulates.
- Perform environmental monitoring of personnel (as needed) and complete documentation.
- Assist in the media fill process validations to include inspection of filled units
- Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
- Verify that raw materials meet specification
- Verify and account for labeling
- Review temperature and BMS alarms
- Verify that product test results meet specification limits
- Verify that all documentation is complete
- Document non-compliance and work with supervisor/lead if further investigation is needed
- Submit samples to the appropriate lab for particulate identification or microbial analysis.
- Assist with equipment calibration program and maintenance record files.
- Assist with raw material release and movement.
- Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
- 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 Quality Manager’s staff meetings
Expertise: Knowledge & Skills
- Knowledge of pharmacy operations and regulatory guidelines.
- Ability to perform calculations.
- Ability to work within established procedures and practices
- Strong organizational skills and attention to detail
- Ability to effectively troubleshoot issues.
Qualifications - Experience/Training/Education/Certification/Etc:
- Minimum of High School Diploma/GED with work experience
- Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.
- Experienced in aseptic operations.
- Experience within a regulated environment
- Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy
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 45 pounds.
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..
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.
- The employee must occasionally lift and/or move up to 45 pounds.
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.