Job TitleCAPS® is part of the B. Braun Group of Companies in the U.S., the nation's largest network of outsourcing admixture pharmacies, delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years.
Job Description
Position Summary:
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.
Essential Duties/Responsibilities:
Perform product inspection for defects, leaks and environmental monitoring of personnel (as needed) and complete 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 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 to work within established procedures and practices Strong organizational skills and attention to detail Ability to effectively troubleshoot issues. Target Based Range19.22 - 24.03 Qualifications - Experience/Training/Education/Certification/Etc:
Required: 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. Desired: Experienced in aseptic 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.
Physical Demands: The employee must occasionally lift and/or move up to 45 pounds.
Work Environment:
Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
What We Offer:
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. Equal Opportunity Employer Veterans/Disabled
