Quality Assurance Specialist Job at Confidential Jobs, Malvern, PA

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  • Confidential Jobs
  • Malvern, PA

Job Description

QA Specialist – Malvern, PA

Responsibilities:

  • Maintain and improve the site’s Quality Management System.
  • Oversee the site’s compliance with cGMPs, corporate policies, and procedures.
  • Creation and maintenance of controlled documentation, including SOPs, Analytical Data, COAs, Methods of Analysis, etc.
  • Review and approval of change control, deviations, CAPAs, and LIRs.
  • Administrator of site training including scheduling, re-training, and training on revised documentation.
  • Review and approve documentation for the disposition of GMP components, raw materials, intermediates, and APIs.
  • Review and approve master and executed batch records for GMP campaigns.
  • Assist in audits.

Qualifications:

  • Bachelor’s of Science Degree with 3-5 years of industry experience
  • Knowledge of regulatory compliance including 21CFR Part 211
  • Strong organizational skills and detail oriented
  • Strong technical writing skills
  • Ability to work independently to meet tight deadlines.
  • Experience working in a synthetic and/or analytical laboratory environment with a focus on small molecule pharmaceuticals highly preferred
  • QA experience in contract manufacturing for the small molecule arena of the pharmaceutical industry preferred.
  • Experience with OSHA regulations preferred

Job Tags

Contract work,

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