About the company:
B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The Company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Guided by its “Sharing Expertise®” philosophy, B.Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.
The B.Braun Group of Companies in the U.S. includes B.Braun, B.Braun Interventional Systems, Aesculap® and CAPS®. B.Braun’s U.S. headquarters is located in Bethlehem, Pennsylvania. The B.Braun Group of Companies employs more than 46,000 employees in more than 50 countries throughout the world. To learn more about B.Braun visit www.BBraunUSA.com.
Job Description:
Central Admixture Pharmacy Services, Inc. (CAPS), a company of B. Braun Medical Inc., is a state licensed pharmacy also operating as a manufacturer registered with the FDA. CAPS services originate from a free-standing facility with a focus to provide daily admixing and delivery of parenteral drugs, solutions, and nutrition.
Pioneered in 1991, CAPS delivers high quality parenteral admixture services and solutions to dynamic and challenging pharmacy environments. CAPS has grown into a national network of state-licensed, FDA-registered pharmacies providing service to over 1000 hospitals and home care customers. From 25 nationwide locations, CAPS pharmacies operate 365 days a year to admix, dispense and deliver labeled patient specific and anticipatory IV prescriptions to our growing family of outsourcing partners. CAPS services allow client based pharmacists to focus less time on compounding IV solutions and more time on clinical work, while saving time and money.
We are currently seeking a Microbiologist I for our San Diego, CA Pharmacy. The Microbiologist I is responsible for leading the CAPS Microbiology team to perform, coordinate, review, and document tests and results in compliance with CAPS Standard Operating Procedures (SOPs) & Regulatory Standards.
Role and Responsibilities:
1. Perform, lead, and schedule routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus with minimal supervision of senior staff.
2. Performs technical review of test results for completeness and compliance to cGMP’s to ensure that excellent documentation, controls and traceability are in place to maintain integrity.
3. Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities.
4. Records and reviews data in controlled notebooks, controlled data sheets, validated spreadsheets including all computational tasks and completes analysis report forms. Maintains neat and legible records.
5. Ensures all laboratory equipment is validated, maintained, and calibrated according to cGMP’s and CAPS requirements.
6. Follows cGMP’s, GLP’s, SOP’s, USP and FDA guidelines in all appropriate functions and notifies supervisor of any observed discrepancies in laboratory or plant operations.
7. Prepares and reviews preparation of media, reagents, test samples and equipment as required.
8. Responsible for the general cleanliness and appearance of respective lab by keeping laboratory equipment, supplies and environment in good operational condition.
9. Responsible for the inventory of lab supplies for routine testing and special studies.
10. Proficient in finished product and raw material testing i.e. Sterility testing, LAL.
11. Proficient in Environmental Monitoring techniques.
12. Proficient or become proficient in Microbial Identification using Vitek.
13. Provides training for lab technicians in all required Microbiology techniques and practices according to procedures and regulation standards.
14. Ability to cross-train in all laboratory functions as needed.
15. Understands and demonstrates aseptic technique.
16. Investigate non-conformance of routine testing specifications, procedures, and protocols.
17. 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 signatures are complete
Evaluate if further investigation is needed
18. Support in Internal (RC, Third Party Consultants) & External audits by regulatory agencies, such as FDA and DEA.
19. Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
20. Interface with CAPS QCCs and vendor representatives.
21. Prepares and releases test reports for CAPS pharmacies.
22. Prepares monthly and quarterly reports.
23. Prepares special study protocols and revises SOPs.
Qualifications and Experience:
- To qualify for this position, candidates must possess a B.S. or B. A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy).
- Minimum of 4 years experience in a QA/QC department of a pharmaceutical or Allied Health Science.
- Knowledge of good analytical and laboratory techniques, pharmacy preparations, cGMP’s, GLP’s, SOP’s, USP and FDA requirements, ability to perform complex pharmacy calculations and adhere to policies and procedures governing pharmacy operations, computer knowledge, good analytical, organizational and interpersonal skills, and ability to meet deadlines is preferred.
- Must be able to work independently, possess strong communication skills, ability to demonstrate leadership skills and must be detail oriented and have multi-tasking capabilities with ability to prioritize.
- May require to travel
How to Apply:
Apply online through company website or LinkedIn
Date Advertisement Posted - 15th November 2015
(Use Requistion Number - 6716 in search box to view listing)
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