Quality Control Coordinator - Chemistry
Company: B. Braun Medical
Posted on: May 16, 2022
Central Admixture Pharmacy Services, Inc.Quality Control
Coordinator - ChemistryUS-AZ-PhoenixJob ID: 2021-19787Type: Regular
Full-Time# of Openings: 1Category: QualityCAPS PhoenixOverviewCAPS
-, 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 Duties
- Perform 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
- Collect Environmental Monitoring samples as necessary
- New staff training
- Sterility 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 limits
- Verify accuracy of labeling
- Perform final disposition of Batch
- Verify that product test results meet specification limits
- Verify that all documentation is complete
- Document non-compliance and evaluate if further investigation
- Submit samples to the appropriate labs for chemical assay and
- 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 actions
- Support Internal & External audits.
- Maintain quality records (equipment calibration and
maintenance, training, deviation and complaint investigation,
environmental monitoring, Certificate of Analysis, clean room
- Participate in Director of Pharmacy's staff meetingsExpertise:
Knowledge & Skills
- Knowledge of pharmacy operations and regulatory
- 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,
- 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. Braun offers an excellent benefits
package, which includes healthcare, a 401(k) plan, and tuition
reimbursement. 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
- 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
- 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 Offer..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, Phoenix , Quality Control Coordinator - Chemistry, Other , Phoenix, Arizona
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