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

B. Braun Medical Inc. (US); Allentown (Lehigh County); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

A healthcare solutions provider is seeking a Quality Technician on the 2nd shift (Mon-Fri 2:30pm-11:00PM) in Allentown, PA. The role involves conducting quality inspections, assisting with release activities, and ensuring compliance with regulatory standards. The ideal candidate should have a minimum of a High School Diploma/GED and 2 years of relevant experience in the pharmaceutical industry. Competitive benefits are offered.

Qualifications

• Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical or medical device.
• Experienced in aseptic operations is desired.
• Experience within a regulated environment is preferred.

Responsibilities

• Perform product inspection for defects and compliance.
• Assist in media fill process validations.
• Support internal and external audits.

Skills

Knowledge of pharmacy operations and regulatory guidelines

Ability to perform calculations

Strong organizational skills and attention to detail

Ability to effectively troubleshoot issues

Education

High School Diploma/GED

Associates Degree in Technical Scientific Discipline

Job description

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

Join to apply for the Quality Technician - CAPS (2nd shift: Mon-Fri 2:30pm-11:00PM) role at B. Braun Medical Inc. (US)

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

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

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.

Other Information

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.

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.

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.

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.