Kelly Services Laboratory Manager in Walton, Kentucky

Lab Manager – Walton, KY

Kelly Scientific Resources is currently seeking candidates for a Lab Manager role for one of our top clients in Walton, KY.

This is a direct hire opportunity with an excellent compensation and benefits package.

Job Summary

The Laboratory Manger will be responsible for the overall operation of a quality control laboratory to include activities involving personnel, and equipment. Additional responsibilities include directing method development, performing technical tests, experiments for process manufacturing, audits, and providing guidance to blending operators. Candidate must have the ability to provide technical assistance to product development, create product specifications, SOPs, control charts, and other related documents. Performs all tasks in a safe manner observing cGMP and quality standards.

Responsibilities:

  • Train Lab Analysts in job functions, methods, cGMP and ICH guidelines.

  • Plan, assign, supervise, and evaluate work performed by Laboratory staff.

  • Handle procedural and technical laboratory problems.

  • Works closely with Quality Assurance and Technical Managers to ensure laboratory data meets all applicable method criteria, client criteria, and the requirements of accrediting bodies.

  • Develop and implement quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with federal regulations.

  • Prepare and maintain applicable records.

  • Provide advanced problem solving, OOS investigation, troubleshooting, interpretation/ consultation, verification of specimen quality and test results.

  • Determine acceptability, condition and physical tests of product raw material & disposition of finished product in accordance with standards and specifications.

  • Ensure quality and integrity of raw materials, in-process, and finished-product in accordance with standards and specifications.

  • Thorough and detail-oriented visual inspections, hands-on inspection, sampling, and documentation for raw materials, in-process and finished products including chemical testing.

  • Documents; recording and summarizing data from sampling, inspections and tests.

  • Laboratory equipment maintenance and validation.

  • Analyzing and interpreting production and quality data.

  • Some administrative activities may be required as needed.

  • Support to R&D process development.

  • Assist in the administration and performance of stability testing.

  • Oversee the phase 1 investigation of any out of specification testing result.

Qualifications:

  • A BS/MS or equivalent degree in Chemistry, with a least 10+ years working full-time in a pharmaceutical laboratory setting.

  • 3 – 5 years of supervisory experience is preferred.

  • Experience working with cGMP regulations and GLP (Good Laboratory Practices).

  • Experience with analytical methods and validations.

  • Ability to work in a fast-paced environment.

  • Ability to apply computer skills covering word processing, spreadsheet analysis

  • Ability to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.

  • Ability to work independently and well with others.

  • Excellent organizational skills and attention to detail.

  • Strong verbal and written communication skills.

  • Must pass Homeland Security background check

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Other Duties:

Please, note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice.

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

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.

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.