CAPS Chemist I

Company: B. Braun Medical
Location: San Diego
Posted on: June 25, 2022

Job Description:

Central Admixture Pharmacy Services, Inc.

CAPS Chemist I

US-CA-San Diego

Job ID: 2022-20157
Type: Regular Full-Time
# of Openings: 1
Category: Quality
San Diego (CAPS San Diego)

Overview
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.


Responsibilities
Position Summary:The Chemist I is responsible for performing instrument qualifications, analytical methods validation, and stability validation for new and existing pharmaceutical products. This position is responsible for performing independent tasks of great complexity with limited guidance from senior personnel, demonstrate high problem solving skills and developing, implementing and managing projects. This position is also responsible for routine CAPS' raw material and finished product sampling and testing and other routine functions as required by CAPS.Responsibilities: Essential Duties

• Review, write, and execute validation and stability protocols for new and existing pharmaceutical products in accordance with USP or FDA guidelines.
• Perform analytical methods validation and instrument qualifications.
• May represent department in contacts with regulatory agencies, including interfacing with FDA investigators.
• Perform routine HPLC or other chemistry analysis of finished products, raw materials, stability and CAPS samples according to established specifications and procedure using various laboratory apparatus.
• Interpret and apply specifications and operating procedures when carrying out both monitoring and testing responsibilities.
• Record data in controlled notebooks and into the validated spreadsheets accurately and thoroughly.
• Perform instrument operation, troubleshooting, and instrument maintenance as required. Prepare standards and reagents according to established procedures and specifications.
• Follow cGMP and CAPS' SOP requirements in all appropriate functions and notify supervisor of any observed issues and problems with the laboratory or testing results.
• Conduct inventory and proper disposal of expired reagents, standards, chemicals used in the laboratory.
• Receive and log in CAPS samples and prepare testing reports.
• Perform proper hazardous waste removal.
• May initiate out-of-specification (OOS) investigation and conduct follow through of the completion.
• Support Special Projects and work with cross-functional group on development of special test methods.
• Adhere to all Safety, Laboratory, and CAPS' policy.Expertise: Knowledge & Skills
  • Work independently
  • Scientific instrumentation and computer skills
  • Interpret scientific data
  • Data compilation techniques
  • Professional demeanor
  • Technical writing skills
  • Project management skills
  • Troubleshooting and minor repairs of analytical instrument such as HPLC, GC, etc.
    Qualifications
    Expertise: Qualifications - Experience/Training/Education/EtcRequired:
    • Bachelor's degree in Chemistry (Master's is a plus).
    • Minimum 2 - 3 years chemistry laboratory experience.
    • Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP.
    • Knowledge in HPLC, GC/MS, ICP/MS, HLPC/MS.
    • Knowledge in EXCEL and PowerPoint is a plus.
    • Domestic TravelDesired:
      • N/A.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 20 pounds..
        Additional Information
        
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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 Sharing Expertise - initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
        
        Notices
        Equal Opportunity Employer Veterans/Disabled
        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.
        PI181972938

Keywords: B. Braun Medical, San Diego , CAPS Chemist I, Other , San Diego, California