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Quality Technician -Overnight Shift

Expired Job

B. Braun Medical Inc. Allentown , PA 18101

Posted 3 months ago

Overview

Central Admixture Pharmacy Services, Inc. (CAPS) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.

State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder. CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States. Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.

CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry. We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.

The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs. CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.

Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures. CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff. Quality Assurance reports are provided to our clients on a quarterly basis.

Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests. CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options. Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.

CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered. CAPS has a variety of delivery options including same day and next day services.

Responsibilities

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 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

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 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.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other

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:

  • 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.


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Quality Technician -Overnight Shift

Expired Job

B. Braun Medical Inc.