Inotiv
Supervisor, Quality Assurance
Inotiv, Rockville, Maryland, us, 20849
Supervisor, Quality Assurance
Location : Location
US-MD-Rockville
ID
2024-5001
Category
Research and Science
Type
Full Time - Permanent
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 MutationMammalian MutationSecondary AssaysCytogeneticsAny 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.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.
There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen.
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!Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.#LI-JM1
#J-18808-Ljbffr
Location : Location
US-MD-Rockville
ID
2024-5001
Category
Research and Science
Type
Full Time - Permanent
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 MutationMammalian MutationSecondary AssaysCytogeneticsAny 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.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.
There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen.
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!Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.#LI-JM1
#J-18808-Ljbffr