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Posted: Monday, February 5, 2018 8:01 AM

Validation Manager Monroe, NC

Kelly Scientific is looking for a Validation manager for one of our top clients in Monroe, NC. This is a direct hire position Monday - Friday. 1st shift.

Responsibility:
  • Provide support for all validation/qualification activities throughout the facility including new and existing products, process validation, equipment qualification, and software validation.
  • Write, review, and execute protocols and final summary reports.
  • Write and review documentation as required for validation activities including risk assessments, mitigation strategies, and investigations of nonconformances.
  • Schedule and plan equipment, process, and software validations to meet approved timelines.
  • Ability to handle multiple projects and work independently.
  • Design and support FAT/SAT activities at vendor facilities as required.
  • Coordinate all validation activities with other departments.
  • Train other Validation personnel, QC personnel, and Production personnel as needed.
  • Purchase supplies and equipment for validation activities.
  • Maintain a working knowledge of critical plant utilities, equipment, and software systems.
  • Support administrative duties as assigned
  • Other duties as assigned.

Authority:

  • Cooperation with external suppliers and other companies are required.
  • Quality representative in validation and qualification activities.
  • Evaluation and disposition of products, including non-conforming product, according to valid QMI documents.
  • Investigation and closure of QIRs and corrections in cooperation with QCM, as related to validation activities.
  • Organize and perform special testing in cooperation with QCM, as related to validation activities.
  • Perform final release of product and reviewing of documents according to valid TP's and SOP's as required for validation activities.
  • Communication and information exchange with affiliated facilities.
  • Editing and distribution of QC documents.
  • Training of QC and production employees regarding procedures and use of equipment related to validations.
  • Functions related to SAP QM module Key User.
  • Write, review, and approve validation documentation.

Job Requirements:

  • Bachelor's degree in Science, Chemistry, Engineering or a related field is required.
  • Must have at least 3 years of experience in the medical device or pharmaceutical manufacturing environment (ISO 13485 preferred).
  • Demonstrated experience validating a wide range of equipment and processes.
  • Demonstrated experience and knowledge of qualifying changes to validated systems, processes, and equipment.
  • Advanced knowledge of cGMP's, GDP's, and regulatory requirements as they relate to qualification and validation activities (IQ,OQ, PQ).
  • Must have ability to interpret engineering drawings.
  • Proficient Computer skills and MS office skills including word processing, spreadsheet, and database software.
  • Must have knowledge of basic statistic and calculations
  • Must have good communication and writing skills, including report writing.
  • Proficient knowledge in applicable chemical calculations preferred
  • Must pass pre-employment examination and qualification test.

Physical Requirements:
  • Must be able to stand and walk for up to 8 - 12 hours.
  • Must be able to lift up to 50 lbs.
  • Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.


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 11,000 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 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 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
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.


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Source: http://www.jobs2careers.com/click.php?id=4738734062.96


• Location: Charlotte

• Post ID: 58302012 charlotte
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