CAPS Chemist I
Company: B. Braun Medical
Location: San Diego
Posted on: May 15, 2022
Job Description:
Central Admixture Pharmacy Services, Inc.CAPS Chemist IUS-CA-San
DiegoJob ID: 2022-20157Type: Regular Full-Time# of Openings:
1Category: QualitySan Diego (CAPS San Diego)OverviewCAPS -, 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. ResponsibilitiesPosition 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.QualificationsExpertise: Qualifications -
Experience/Training/Education/Etc Required:
- 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 Travel Desired:
- 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 ..What We OfferB. 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.NoticesEqual Opportunity Employer Veterans/DisabledAll
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.
Keywords: B. Braun Medical, San Diego , CAPS Chemist I, Other , San Diego, California
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