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Kelly Services QA Specialist - Pharmaceuticals in Fenton, Missouri

Direct-Hire Pharmaceutical QA Specialist - Fenton, MO

  • Mon-Fri 8am-5pm

  • Relocation available for the right candidate

  • Compensation: $60,000-70,000 dependent on experience

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

Responsibilities:

  • 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.

Qualifications:

  • Minimum Education: Bachelor’s degree in Chemistry, Pharmaceutical Science, Biology, or related

  • Minimum 2 years Quality Assurance experience in a GMP regulated environment

  • 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

  • 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.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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