CAPS QC Coordinator - Chemist
Company: B. Braun Medical
Location: Allentown
Posted on: June 23, 2022
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Job Description:
Central Admixture Pharmacy Services, Inc.CAPS QC Coordinator -
ChemistUS-PA-AllentownJob ID: 2022-21080Type: Regular Full-Time# of
Openings: 1Category: QualityCAPS Lehigh ValleyOverviewCAPS--, 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.PI182168482
Keywords: B. Braun Medical, Allentown , CAPS QC Coordinator - Chemist, Other , Allentown, Pennsylvania
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