Pharmaceutical Quality Assurance Manager

5 days ago


Dallas, Texas, United States Synergy Bioscience Full time

Job Description

We are seeking an experienced GMP QA and Compliance Professional to join our team at Synergy Bioscience in Dallas, Texas. This role involves ensuring the compliance of laboratory operations and quality system writing, with a focus on regulatory requirements.

Key Responsibilities:

  • Coordinate quality system documentation, aligning with 21 CFR Parts 11, 210, 211, 600s, and 820, as well as ISO 17025, EPA, and CLIA regulations.
  • Write SOPs and WI to meet regulatory compliance requirements.
  • Develop and deliver training on QA procedures and critical needs.
  • Oversee quality assurance compliance activities, including tracking deviations, OOS investigations, and CAPAs.

Requirements:

  • Bachelor's in Chemistry, Biology, or Pharmaceutical with a minimum of 5 years industry experience.
  • Masters in Chemistry, QA, and Regulatory Affairs with a minimum of 3 years industry experience.
  • Previous experience in pharmaceutical quality systems functions.
  • Strong written and oral communication skills.
  • Attention to detail and problem-solving abilities.

Salary Range:$85,000 - $120,000 per year, depending on experience.



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