QA Microbiologist II

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:
Responsibilities: Essential Duties.

• 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 data integrity.
• Provides training for lab technicians in all required Microbiology techniques and practices according to procedures and regulation standards.
• Performs microbiological testing: microbial identification, bioburden, sterility test, growth promotion, particulate matter, bacteriostasis & fungistasis, LAL Kinetic Turbidimetric / Gel-clot methods, and other testing for special studies.
• Ensures all laboratory equipment is validated, maintained and calibrated according to cGMP's and B Braun requirements.
• Initiates investigation of out-of- specification test results and procedure / protocol deviations.
• Interface with CAPS Quality Control Coordinators and vendor representatives.
• Prepares and releases test reports for CAPS Pharmacies.
• Reviews, trends, and reports environmental monitoring data for CAPS pharmacies.
• Maintains neat and legible records and promptly and accurately inputs data into computer system.
• Prepares monthly report for CAPS QC Microbiology.
• Prepares special study protocols and revises Standard Operating Procedures.
• Responsible for the inventory of lab supplies for routine testing and special studies.
• Responsible for the general cleanliness and appearance of the laboratory
• Quality, technical data review and investigation oversight.
• Collaborate with all departments and reports metrics to site management to continuously drive quality improvements.

Expertise: Knowledge & Skills

• Familiar with Data Integrity and GDP in a cGMP Laboratory environment.
• Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP's. (Complete knowledge of good analytical and laboratory techniques, basic knowledge of cGMP's, GLP's, SOP's, USP and FDA requirements).
• Ability to work effectively in a multi-cultural environment.
• Good analytical skills
• Interpersonal skills
• Ability to meet deadlines
• Good organizational skills
• Must be able to work independently
• Strong communication skills
• Ability to demonstrate leadership skills
• Must be detail-oriented and have multi-tasking capabilities with the ability to prioritize.

#ID
#LI
#MSL
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
Target Based Range
87,180
Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:

• Bachelors of Science in Microbiology or related discipline with at least 5 years pharmaceutical industry and QC laboratory experience.
• Proven and/or demonstrated skills/abilities in leadership, educational training and/or experience will be taken into consideration.
• Previous supervisory experience.
• cGMP training/experience required.
• Aseptic processing training/experience desired. Training will be provided.

Desired:

• Advanced degree preferred.

Additional Information
Physical Demands:
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.
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 bend, twist, stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

• 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.

Work Environment:
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.

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

What We Offer
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.
Notices
Equal Opportunity Employer Veterans/Disabled