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.
Responsibilities: Essential Duties
∙ Supervises workers and tasks within the quality assurance function of an organization.
∙ Supervises audit or inspection processes meant to monitor compliance with established quality standards.
∙ Coordinates and reviews the work of a team of analysts or inspectors that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations.
∙ Assists team members in interpreting quality standards.
∙ Summarizes team findings and prepares reports for management.
∙ Suggests changes to vendors or purchasing/production procedures with the goal of improving processes or products.
∙ Leads root cause analysis and corrective/preventive actions for laboratory investigations and product complaints.
∙ Ensures all laboratory equipment is validated, maintained and calibrated according to cGMP’s and CAPS requirements.
∙ Plans and organizes microbiological testing activities within the lab: microbial identification, bioburden, sterility test, growth promotion, particulate matter, bacteriostasis & fungistasis, LAL Kinetic Turbidimetric / Gel-clot methods, and other testing for special studies.
∙ Conducts visual and physical inspections of company products and materials.
∙ Develops, implements and assesses processes and policies designed to test products and services.
∙ Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
∙ Enforces regulatory compliance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons."
Expertise: Knowledge & Skills
Expertise: Qualifications -Education/Experience/Training/Etc
cGMP training/experience 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.
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.
While performing the duties of this job, the employee is expected to:
Lifting, Carrying, Pushing, Pulling and Reaching:
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.
Equal Opportunity Employer Veterans/Disabled