CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.
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
Expertise:Qualifications - Experience/Training/Education/Etc:
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
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.
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 (url removed).
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.
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.
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.
Equal Opportunity Employer Veterans/Disabled