Quality Technician - Microbiology
Company: B. Braun Medical
Location: Allentown
Posted on: January 23, 2023
Job Description:
Central Admixture Pharmacy Services, Inc.Quality Technician -
MicrobiologyUS-PA-AllentownJob ID: 2022-21759Type: Regular
Full-Time# of Openings: 1Category: QualityCAPS Lehigh
ValleyOverviewAbout CAPS -CAPS is the nation's largest network of
outsourcing admixture pharmacies. A pioneer in the outsourcing of
CSPs, CAPS was founded in 1991, and delivers high-quality,
same-day, admixture services and solutions to hospitals and
outpatient facilities across the nation. CAPS has three 503B
Outsourcing Facilities that are registered with the FDA to provide
anticipatory compounding services. CAPS also has 22 state licensed
503A regional pharmacies that dispense labeled, patient-specific
prescriptions. To learn more, visit www.capspharmacy.com.
ResponsibilitiesPosition Summary: Ensure and assist with
site-specific quality compliance according to CAPS Standard
Operating Procedures (SOPs) & specifications, quality review of
documents, label control, assist with release activities and
product inspections. Essential Duties/Responsibilities:
- Perform product inspection for defects, leaks and
particulates.
- Perform environmental monitoring of personnel (as needed) and
complete documentation.
- Assist in the media fill process validations to include
inspection of filled units
- Perform document review of compounding activities such as
cleaning records, line clearance forms and inventory sheets:
- Verify that raw materials meet specification
- Verify and account for labeling
- Review temperature and BMS alarms
- Verify that product test results meet specification limits
- Verify that all documentation is complete
- Document non-compliance and work with supervisor/lead if
further investigation is needed
- Submit samples to the appropriate lab for particulate
identification or microbial analysis.
- Assist with equipment calibration program and maintenance
record files.
- Assist with raw material release and movement.
- Under the direction of supervisor/lead, document and initiate
quality events for deviation and complaint investigations.
- Support 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 Quality Manager's staff meetingsExpertise:
Knowledge & Skills
- Knowledge of pharmacy operations and regulatory
guidelines.
- Ability to perform calculations.
- Ability to work within established procedures and
practices
- Strong organizational skills and attention to detail
- Ability to effectively troubleshoot
issues.IN2017QualificationsQualifications -
Experience/Training/Education/Certification/Etc: Required:
- Minimum of High School Diploma/GED with work experience
- Minimum of 2 years experience in a quality or manufacturing
department of a pharmaceutical, Medical Device or Allied Health
Science.Desired:
- Experienced in aseptic operations.
- Experience within a regulated environment
- Associates Degree or higher level degree in Technician
technical scientific discipline, Biology, Microbiology, Chemistry
or Pharmacy.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 45
pounds. 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. 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:
- The employee must occasionally lift and/or move up to 45
pounds. 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.PI201507739
Keywords: B. Braun Medical, Allentown , Quality Technician - Microbiology, Professions , Allentown, Pennsylvania
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