QC Coordinator - Chemistry
Company: B. Braun Medical
Location: San Diego
Posted on: January 26, 2023
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Job Description:
Central Admixture Pharmacy Services, Inc.QC Coordinator -
ChemistryUS-CA-San DiegoJob ID: 2022-20796Type: 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:Ensure site-specific compliance
with CAPS Standard Operating Procedures (SOPs). Responsibilities:
Essential DutiesPerform and review the Daily Compliance
Verification Checklist, document results, and report to immediate
supervisor.Perform and/or coordinate completion of:Environmental
monitoring and documentation e.g. personnel monitoring, air
bioburden, surface bioburden, temperatures, and particle counts
Collect Environmental Monitoring samples as necessaryNew staff
trainingSterility tests, aseptic technique qualifications, and
media fill process validations.Perform Document review of
anticipatory and as appropriate non-sterile to sterile compounding
batch records:Verify that raw materials meet specification
limitsVerify accuracy of labelingPerform final disposition of
BatchVerify that product test results meet specification
limitsVerify that all documentation is completeDocument
non-compliance and evaluate if further investigation is needed
Submit samples to the appropriate labs for chemical assay and
microbial tests.Track vendor equipment calibration and maintenance
records and assess for deviations.Enter test results or summaries
into the pharmacy specific monthly and quarterly Quality Assurance
report template.Under the direction of supervisor, document results
of deviation and complaint investigations, causal analysis,
corrective actions and preventive actionsSupport 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 Director of Pharmacy's staff
meetingsExpertise: Knowledge & SkillsKnowledge of pharmacy
operations and regulatory guidelines.Ability to perform pharmacy
calculations. Responsibilities: Other Duties As assigned by
immediate supervisor.QualificationsExpertise: Qualifications -
Experience/Training/Education/EtcRequired:B.S. or B.A. degree in
Science (Biology, Microbiology, Chemistry, Pharmacy) Minimum of 2
years experience in a QC/QC department of a pharmaceutical or
Allied Health Science.As assigned by Supervisor.Desired:Minimum of
2 years experience in pharmacy preparation.Pharmacy Technician
Certification. 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 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:Some travel may be required.Ability to stand and/or sit for
long periods of time.Ability to reach, grasps, stoop, pull and
perform repetitive motion procedures.Ability to lift up to 20 lbs.
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.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.PI202091220
Keywords: B. Braun Medical, San Diego , QC Coordinator - Chemistry, Other , San Diego, California
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