Quality Systems Supervisor

Job Summary:

The Quality System Supervisor will assist and recommend in developing and implementing procedures and practices used in the Quality System of a GMP aseptic fill manufacturing facility. This position will oversee and ensure the duties in the Quality System are completed in a timely and accurate manner.

Job Scope:

The Quality System is integrated with the other five manufacturing systems. It is critical for this position to understand Nova-Tech’s GMP culture and the concept of Laboratory Control (LC) functions and the manufacturing process. The Quality System Supervisor will work closely with management and other manufacturing supervisors to participate in the Master Validation Plan, documentation, new product assessment and development, and develop depth for GMP and facilitate its implementation. This position will be familiar with FDA and industry guidelines, and interpret them in order to provide GMP expertise to assist in establishing and determining manufacturing procedures, standards, and control points as appropriate based on established validated processes.

Responsibilities:

· Supervise Quality System Technicians and assign and monitor their responsibilities; provide assistance in areas of need

· Recommend the hiring, firing, advancement, promotion or any other change of status of employees to the Quality System Manager

· New and existing equipment and instrument qualifications

· Maintain calibration program

· Executing Master Validation Plan. Work with Project Manager for document review.

· Assist in internal and external validation of manufacturing processes including steam sterilization, media fill, cleaning validation, process validation, and irradiation validation

· Manage in change controls

· Internal and vendor audits

· Establish and revise applicable Standard Operating Procedures and forms

· Implement customer quality specifications

· Administer drug product recalls

· Participate in development and management new product project management

· Participate in investigations such as deviations, OOS, and compliance. Follow through with assigned CAPA.

· Shared cleaning of work area

· May work in Production in time of need

· Other duties as assigned

Knowledge and Job Skills:

· Detail oriented with organizational skills and ability to multi task and meet deadlines

· Experienced in equipment and instrument qualification and process validations

· Critical and systematic thinking and problem solving skills

· Good composition, data input, and analysis skills

· GMP knowledge of manufacturing processes

· Must be able to frequently lift, push, pull or move up to 50lbs

Minimum Education and Experience:

· BS graduate with background knowledge in natural science curriculum. Physical and life science is a plus.

· Minimum of three years supervising experience in a regulated industry

· Ability to read, write, speak, and understand English sufficiently to perform the duties of this position

Pre Employment Screening:

· Drug Screening including use of tobacco

· Background Screening

· Visual Acuity Screening

Benefits Summary:

· Group Insurance Plan including Health, Dental, Vision, Voluntary Life, Short-Term Disability, Critical Illness, and Accident Expense

· Long-Term Disability Insurance

· Whole Life Insurance

· Flex Savings Plan

· Safe Harbor 401(k)

· Paid Vacation

· Holiday, Sick, and Birthday Pay

· Direct Deposit

· Paid Uniforms, including Safety Shoes

Pay: From $60,919.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Are you a tobacco or nicotine user?

Experience:

• Supervising: 3 years (Required)

Work Location: In person

Salary : $60,919