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.
Responsible for leading the CAPS QC Microbiology team to support CAPS pharmacies with microbiological testing and special projects.
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.
- Computer knowledge
- 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.
Expertise: Qualifications - Experience/Training/Education/Etc
- 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.
- Advanced degree preferred.
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.
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.
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.
- Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.