Summary: It is the responsibility of the QA Supervisor to work with and assist QA management in project management, development, implementation and enforcement of quality policies, procedures and programs. The QA Supervisor shall assume the responsibilities for overseeing all Captek’s internal QA matters.
Duties and Responsibilities:
• The QA Supervisor is responsible for the supervision of all QA Leads, Technicians, and Document Control Specialists.
• Schedule and coordinate work assignments for the department/shifts
• Assure compliance with quality requirements
• Plan and set goals and objectives for department
• Conduct job performance reviews
• Initiate disciplinary actions and investigates incidents when required
• Trend and drive site’s internal quality performance
• Perform and/or coordinate training of department personnel, as needed
• Responsible for interviewing and hiring personnel
• Conduct investigations concerning operational problems, non-conformance’s, failures, and/or any other such quality investigations.
• Assist in development of corrective actions, implementation and follow-up of corrective action.
• Assist in revising and approving quality and process control procedures
• Participate in developing, interpreting, and implementing policies and procedures for the area of responsibility
• Analyze quality data and make recommendations for improvement
• Assist in preparation of customer and regulatory audits
• Perform other related duties as assigned by VP of Q&R
Minimum of 5 years relevant work experience with 1 year in a Supervisory role Experience managing and scheduling a shift of five (5) or more employees. Experience in training personnel
Strong verbal and written communication
Good attendance and punctuality, Ability to follow instructions
Excellent organizational skills/ attention to detail/ ability to work effectively in a fast-paced environment
Strong proficiency in using Microsoft Word, Excel, Outlook and Power Point
Ability to set priorities, be flexible, multi-task and meet deadlines
Ability to manage time and work under pressure with minimal supervision
Strong working knowledge of quality systems
•Minimum AA degree in health science or related discipline. Bachelor’s degree preferred. Two years of work related experience may substitute for one year of college education.
•Working knowledge of cGMPs and FDA regulations
•ASQ CQA and/or CHA certification preferred
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.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.
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.
Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.