Quality Technician - CAPS Process Control (2nd shift: Mon-Fri 2:30pm-11:00PM)

• Company: **Central Admixture Pharmacy
• Job Posting Location: **Allentown (6845 Snowdrift Rd), Pennsylvania, United States
• Functional Area: **Quality
• Working Model: **Onsite
• Days of Work: **Friday, Thursday, Wednesday, Tuesday, Monday
• Shift: **5X8
• Relocation Available: **No
• Requisition ID: **7098
  
  

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®, part of the B. Braun Group of Companies in the U.S., is 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®, part of the B. Braun Group of Companies in the U.S., is 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.

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, lean 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.
  
  

Required

**Qualifications - Experience/Training/Education/Certification/Etc:**

• 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.
• Schedule (2nd shift) Monday-Friday 2:30-11:00PM
  
  

Salary range is $20.39-$25.49/hr

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.
• Experience with Process Control, AQL, GMP and GDP
  
  

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.

**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.

The targeted range for this role takes into account a range of factors that are considered