Quality Assurance Supervisor

6 days ago

Rockville, Maryland, United States Inotiv Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Supervisor to join our team at Inotiv. As a Quality Assurance Supervisor, you will be responsible for overseeing all Quality Assurance (QA) functions, including audits of ongoing operation processes, protocol review, data, study reports, and general study compliance with regulatory requirements and SOPs.

Key Responsibilities:

  • Oversee QA team, including the growth and development of QA auditors.
  • Solid understanding of pharmaceutical federal regulations (i.e. GLP, GCP).
  • Experience in the preparation and implementation of SOPs, protocols, and other documents in accordance with FDA regulations, including GLP.
  • Experience in the preparation, approval, and tracking of deviations, project investigations, and CAPA.
  • Ability to streamline and coordinate local quality processes.
  • Experience managing regulatory and sponsor audits, responding to customer and regulatory audits, and follow-up on observations and identified corrective or preventative actions.
  • Partner with leadership and operations as a resource and guide to support all regulated activities.
  • Ensure maintenance of validated state of computer systems throughout their lifecycle in accordance with 21 CFR 58, 21 CFR 11, and other relevant regulations and guidelines.
  • Ability to keep abreast of new rules, guidance, and industry standards to ensure that the Inotiv Rockville site maintains a fully compliant program.
  • Quality management experience in the pharmaceutical industry is preferred.

Requirements:

  • B.S/B.A. in Biology, Chemistry, or other life science with 5 years of auditing experience or equivalent experience.
  • Supervisory experience is preferred.
  • Excellent written and verbal communication skills.
  • Excellent time management skills.

What We Offer:

At Inotiv, we offer a competitive salary range of $80,100-96,200, commensurate with experience, skills, education, certification, responsibilities, and location. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more.

About Inotiv:

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.

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