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Quality Assurance Specialist

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Yoh

2024-09-27 08:38:11

Job location Noblesville, Indiana, United States

Job type: fulltime

Job industry: Engineering

Job description

Yoh is seeking a Quality Assurance Specialist for our pharmaceutical client in Noblesville, Indiana.

Pay: $30-$36/hr.
Hours: M-F, 8:00 am - 4:30 pm
Type: Contract - 6 months

Responsibilities

  • Review and edit documents for accuracy, completeness, and consistency.
  • Perform QA on the Floor function.
  • Gown into a grade C and D environment.
  • Monitor aseptic operations for Quality Assurance.
  • Review batch record completeness for accuracy and compliance.
  • Review and release incoming materials for accuracy and compliance.
  • Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.
  • Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).
  • Support regulatory and client audits.
  • Conducts internal audits of the QMS and sub systems.
  • Analyze data to identify areas for improvement in the quality system.
  • Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).


Requirements
  • Bachelor Degree in Science or related field required.
  • 3 or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance
  • Knowledge of tools, concepts and methodologies of Quality.
  • Auditing experience, along with deviation and lot release support.


Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

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 to contact us if you are an individual with a disability and require accommodation in the application process.

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