Quality Associate (Microbiology)

Quality Associate Exempt

Job Description:

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.

Responsibilities:

Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. Write, review, analyze and revise written Standard Operating Procedures SOPs and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Support external assessments or audits. Assist with audits of various reports Protocols, Qualifications, Regulatory Submissions, etc. Serve as Subject matter Expert SME and provide training to local employees as needed on relevant areas 

Requirements:

  • Bachelor s Degree in Microbiology Required .
  • One 1 to Three 3 years in Manufacturing Industry working with Microbiology testings, deviations, Investigation processes and Non-conformance processes.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Strong team player with good problem solving, and good verbal and written communication skills.
  • Good ability to manage people, encourage teamwork and drive decisions.
  • Able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate. 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

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. 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.

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