Quality Technician - CAPS (2nd shift)

RXinsider LTD.; Allentown (Lehigh County); On-site; USD 29,000 - 36,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

Central Admixture Pharmacy in Allentown, PA, is seeking a on-site Quality Inspector for the CAPS network on a 2nd shift to ensure site-specific quality compliance, review SOPs, label control and assist with release activities and product inspections.

You will perform product inspections for defects, monitor environmental conditions, support media fill validations and review documentation to ensure raw materials, labeling and temperatures meet specifications.

Qualifications

• 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.
• Associates degree or higher in Technician, biology, microbiology, chemistry or pharmacy is desirable.

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

Skills

Pharma operations

Calculations

Procedures adherence

Attention to detail

Troubleshooting

Education

High School Diploma or GED

Associate degree or higher (Tech/Science/Pharmacy)

Job description

Company: Central Admixture Pharmacy

Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Wednesday, Tuesday, Thursday, Friday, Saturday, Monday, Rotating, Sunday

Shift: 5X8

Relocation Available: No

Requisition ID: 10992

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

CAPS®, 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.

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 - 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.

Schedule

• Schedule: (2nd shift) M‑F 2:30pm to 11:00pm


• Salary range is $21.00-$26.25/hr

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.

Work Environment

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All 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.

Compensation details

21-26.25 Hourly Wage