QA Supervisor-CAPS

Company: CAPS Lehigh Valley
Location: Allentown
Posted on: March 12, 2023

Job Description:

OverviewAbout CAPS--, 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. ResponsibilitiesPosition Summary: 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

• Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
• Provides direct or indirect supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
  • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
  • Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
  • Judgement is required in resolving complex problems based on experience.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
  • Ability to analyze samples to determine Microbial enumeration methods, absence of specified microorganism and other testing analysis including environmental monitoring of production areas.
  • Devises and develops processes and methods for the solution of technical problems.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals.
  • May periodically assist in orienting, training, assigning and checking the work of lower-level employees. Referring only complex problems and issues.
  • Familiar with Data Integrity and GDP in a Lab environmentQualificationsExpertise: Qualifications -Education/Experience/Training/Etc Required:
    • Bachelor's degree required.
    • 02-04 years related experience required.
    • Applicable industry/professional certification preferred.
    • Regular and predictable attendance
    • Ability to work non-standard schedule as needed 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.PI207551493

Keywords: CAPS Lehigh Valley, Allentown , QA Supervisor-CAPS, Other , Allentown, Pennsylvania