Kelly Services QC Microbiology Supervisor - Phoenix, AZ in Phoenix, Arizona

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QC Microbiology Supervisor (2nd shift) - Phoenix, AZ

We have an exciting opportunity for a 2nd shift QC Microbiology Supervisor for one of our top candidates in Phoenix, AZ that focus on pharmaceutical manufacturing,.

Summary: The Supervisor, QC Microbiology Environmental Control supervises and oversees the activities and personnel in the Environmental Control group as they perform routine and non-routine microbiological testing in support of sterile product manufacturing. Trends results within a lab environmental, reviews documents, trains company personnel, writes procedures, protocols, investigations and CAPA’s. This includes carrying out responsibilities independently in accordance with the organization’s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements at all times.

Duties and Responsibilities:

  • Ensure employees are properly trained and qualified.

  • Train and mentor subordinates and other department analysts.

  • Provide performance evaluations and support career development of direct reports.

  • Participates in aseptic process qualifications: Aseptic gowning, Media fills.

  • Documents, Tracks, and Trends test results:

  • Performs review of critical cGMP documents supporting batch release and controlled area status.

  • Creates, maintains, and delivers controlled and aseptic area training modules.

  • Serve as author and/or technical reviewer of department operating procedures.

  • Oversee and prepare written monthly/yearly QC Microbiology environmental trend reports.

  • Prepare protocol, summary, document change and investigational reports as needed.

  • Assign weekly job responsibilities to analysts performing routine and non-routine environmental control functions and ensure all tasks are performed timely and correctly.

  • Utilize scientific principles to assist in troubleshooting and problem solving for EC microbiology deviations.

  • Perform Media Fill Growth Promotion.

  • Plans and develops special project work.

  • Perform microbial isolation techniques and perform Gram stain identifications.

  • Initiate and performs Deviation Investigations/CAPA’s associated with Microbiological testing.

  • Act as liaison with other departments by representing QC Microbiology at cross functional team meetings.

  • Write and review Technical and business documents.

  • Effectively communicates with department management and cross-functional management.

  • Perform QC Microbiology related Deviation Investigations and Corrective Actions.

  • Serve as author and/or technical reviewer of department operating procedures.

  • Oversee and prepare written monthly/yearly QC Microbiology environmental trend reports.

  • Prepare protocol, summary, document change and investigation reports as needed.

  • Perform other duties as assigned.

Minimum Requirements:

  • Bachelor’s degree preferred, preferably in Microbiology or related science.

  • 4 years’ relevant work experience required, preferably in a Pharmaceutical manufacturing environment with cGMP requirements.

  • An equivalent combination of experience/education is acceptable

  • Ability to deal appropriately with Regulatory agencies.

  • Flexibility and ability to multi-task.

  • Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.

  • Advanced knowledge of OSHA and DEA.

  • Advanced MS Word, Outlook, Excel, MS PowerPoint, Visio.

  • Advanced problem Solving skills.

  • Strong organization and time management.

  • Strong critical reasoning and decision making.

  • Strong teamwork and facilitation skills.

  • Able to develop and motivate others delegate and solve routine problems.

  • Ability to gown and maintain a sterile work environment.

  • Ability to pass an initial full physical with annual monitoring.

APPLY TODAY! Questions? Contact Kevin at 602-548-1774 or email at kevin.lau@kellyscientific.com

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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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

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You pursued a career in science to fuel your quest for knowledge and your desire to make the world

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AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.