Quality Technician - Microbiology

Company: CAPS Lehigh Valley
Location: Allentown
Posted on: May 16, 2022

Job Description:

OverviewCAPS -, 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 nation's 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.ResponsibilitiesPosition 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 particulates.Perform environmental monitoring of personnel (as needed) and complete documentation.Assist in the media fill process validations to include inspection of filled unitsPerform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:Verify that raw materials meet specificationVerify and account for labelingReview temperature and BMS alarmsVerify that product test results meet specification limitsVerify that all documentation is completeDocument non-compliance and work with supervisor/lead if further investigation is neededSubmit 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 meetingsExpertise: Knowledge & SkillsKnowledge of pharmacy operations and regulatory guidelines.Ability to perform calculations.Ability to work within established procedures and practicesStrong organizational skills and attention to detailAbility to effectively troubleshoot issues.QualificationsQualifications - Experience/Training/Education/Certification/Etc:Required:Minimum of High School Diploma/GED with work experienceMinimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.Desired:Experienced in aseptic operations.Experience within a regulated environmentAssociates 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...PI177647817

Keywords: CAPS Lehigh Valley, Allentown , Quality Technician - Microbiology, Professions , Allentown, Pennsylvania