Microbiologist I
Location:
San Diego , California
Posted:
October 23, 2017
Reference:
2017-10621
Overview
Central Admixture Pharmacy Services, Inc. (CAPS®) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.

State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder. CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States. Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.

CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry. We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.

The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs. CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.

Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures. CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff. Quality Assurance reports are provided to our clients on a quarterly basis.

Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests. CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options. Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.

CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered. CAPS has a variety of delivery options including same day and next day services.

Responsibilities
Position Summary:
Analyzes environmental monitoring and microbiological trends. Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls in compliance with CAPS Standard Operating Procedures (SOPs) & Regulatory Standards. Prepare and present technical microbiology and sterility assurance investigative and trend reports to management. Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations.

Responsibilities: Essential Duties
  • Analyzes environmental monitoring and microbiological trends.
  • Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls.
  • Prepare and present technical microbiology and sterility assurance investigative and trend reports to management.
  • Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations.
  • Perform, lead, and schedule routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus, as necessary
  • 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.
  • Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities.
  • Prepares and reviews preparation of media, reagents, test samples and equipment as required.
  • Proficient in finished product and raw material testing i.e. Sterility testing, LAL.
  • Proficient in Environmental Monitoring techniques.
  • Proficient in Microbial Identification
  • Understands and demonstrates aseptic technique.
  • Support in Internal (RC, Third Party Consultants) & External audits by regulatory agencies, such as FDA, BOP, and DEA.
Expertise: Knowledge & Skills
  • Knowledge of good analytical and laboratory techniques, pharmacy preparations, cGMP's, GLP's, SOP's, USP and FDA requirements
  • Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls
  • Good analytical, writing, interpersonal, and organizational skills
  • Ability to meet deadlines
  • Must be able to work independently
  • Strong communication skills
  • Ability to demonstrate leadership skills
  • Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
  • Software packages supporting statistical data analysis, word processing, and project management


Qualifications
Expertise: Qualifications-Experience/Training/Education/Etc

Required:
  • B.S. degree in Microbiology, or equivalent experience
  • 3 - 5 years experience in Pharmaceutical / medical device industry
  • Valid drivers license required
  • Up to 25% travel required
Desired: N/A

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. 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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other
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.

IN2017

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