QA Specialist/Technician

MAC Incorporated

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QA Specialist/Technician Fenton, Missouri
Job Ref:
36423

 

Quality Assurance Specialist

 

 

 

Function:           The Quality Assurance Specialist will be responsible for ensuring day to day quality assurance activities are executed in compliance with all applicable regulations.

 

Essential Functions of the Position:

  • Maintain and act as administrator of the employee training records (electronic training management/paper).
  • Maintain compliance oversight (auditing responsibility) of the training program.
  • Provide training on quality assurance and FDA compliance topics.
  • Oversight of the vendor management program.
  • Conduct internal and vendor auditing.
  • Ensure that daily Quality Assurance Departmental activities support operational requirements (componentry inspection and release, document control system, label issuance/control, etc.).
  • Perform batch record issuance/review to ensure all products meet company/regulatory standards and customer expectations.
  • Complete investigations and failure analyses so that root causes for deviations are understood and eliminated where possible.
  • Write standard operating procedures.
  • Support label control program to assure compliance with issuance accountability, change and processing controls.
  • Disposition raw materials for use in pharmaceutical goods.
  • Review and approve analytical method validations.
  • Support Quality Manager in assuring that requirements of the Code of Federal Regulations are met.
  • Other duties, which may be assigned from time to time.

Skills and Abilities Required:

  • Knowledge of Federal and State Regulations
  • Knowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies
  • Strong organizational skills with high attention to detail
  • Strong communication skills
  • Possess excellent computer (MS office: Word; Excel; Access; Outlook), writing and editing skills

Minimum Education and Experience Required:

  • Minimum Education: Bachelor’s degree
  • Minimum 2 years Quality Assurance experience in a regulated environment

Physical Requirements:

  • Ability to physically work in an FDA regulated environment.
  • Ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • May be required to sit or stand for long periods of time.
  • Some lifting <25lbs.
  • Ability to see accurately and in color, and have good hand eye coordination.

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