Quality Technician - CAPS
Central Admixture Pharmacy Services, Inc.Quality Technician - CAPSUS-PA-AllentownType: Regular Full-Time# of Openings: 1Category: QualityCAPS Lehigh ValleyOverviewCAPS, the nations 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.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 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 Managers 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.The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.#LI#EL#IDTarget Based Range$17.21-$21.52QualificationsQualifications - 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 operations.
Experience within a regulated environment
Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmac .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 poundsAdditional InformationResponsibilities: 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:
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.Work Environment:
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.What We OfferB. Braun offers an excellent benefits package, which includes healthcare, a 401k 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.NoticesEqual Opportunity Employer Veterans/DisabledAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.PI249785783