Supervisor, Quality Assurance - Rockville

Overview:

Quality Assurance Supervisor

Responsibilities:

Skills and Responsibilities:

• Responsible for 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.
• Oversees 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 and trending 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.
• Partners 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 preferred.
• Ensures site compliance with US FDA and other regulatory requirements, including other guidance and publications.
• Reviews and maintains Standard Operating Procedures (SOP) to ensure they remain current and compliant with relevant regulations.
• Supervisor will coordinate auditing activities as related to GeneTox assays including but not limited to assays performed in the following labs:
• Bacterial Mutation
• Mammalian Mutation
• Secondary Assays
• Cytogenetics
• Any other IND-enabling mechanistic assays conducted in support of issue resolution

Corporate Responsibilities:

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to applicable company policies and guidelines.
• Adherence to federal and/or local regulations, as applicable.

Qualifications:

• B.S/B.A. in Biology, Chemistry or other life science with 5 years of a auditing experience or equivalent experience.
• Supervisory experience preferred.
• Excellent written and verbal communication skills.
• Excellent time management skills.
• This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range for this role is $80,100- 96,200 and could adjust along with the level of the role to match the person’s relevant experience and/or education level.

Join us in embracing research and science to impact the health and well-being of people all over the world.

Inotiv has been named a 2023 Top Workplace!

The annual salary range of (69,700- 90,700) 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!

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

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