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Quality Control Analyst, Method Steward Job at Yoh, A Day & Zimmermann Company

Yoh, A Day & Zimmermann Company Waltham, MA

Quality Control Specialist / Method Steward

Contract with perm potential

100% Onsite in Lexington, MA

Pay rate: TBD, depending on experience level

***Please note, candidates applying for this role need 3 – 5 years of validation experience and experience working in GMP, cGMP environments.

Other experience:
  • A Bachelor's degree in in Life Sciences or Engineering
  • A minimum of 3 years’ experience with validation in a quality controlled environment
  • Understanding of cGMP regulations
  • Familiarity with Microsoft Office
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities with challenging timelines
Summary: This role reports to the QC Manager and will be responsible for providing manufacturing support. Assist with performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, and preparation of cGMP materials.

Key Responsibilities:
  • Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
  • Support investigations into protocol nonconformances and site
  • Author standard operating procedures related to validation
  • Support the execution and generation of formal risk
  • Support the generation and implementation of validation
  • Represent the validation department at team
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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