Job Description

You\'re an important part of our future. Hopefully, we\'re also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That\'s why we would like to keep developing our company with you. Keeping your future in mind, we\'re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That\'s Sharing Expertise.

Quality Technician - CAPS

Reference Code US-PAH133-81326

CAPS\xc2\xae, 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.

Duties and 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.
• 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.
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Professional competencies

• 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.
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What we offer

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 \xe2\x80\x9cSharing Expertise\xc2\xae\xe2\x80\x9d initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

B. Braun