•Interact with clients, other employees, and the community in a professional manner
•Support and participate in company initiatives as directed
•Maintain thorough knowledge of facility SOPs, policies, study protocols, etc.
•Adhere to all safety regulations and procedures
•Provide assistance or support to other Inotiv QA team members as necessary
Quality Assurance Auditor I
Position Requirements
Education and Experience
- B.S. in chemistry or life sciences or
- B.S./B.A. in related field with 1-3 years pharmaceutical auditing experience or
- 3-5 years of pharmaceutical laboratory experience with 1 year of auditing experience or
- Equivalent combination of education and regulatory, quality, compliance and/or industry experience.
Skills and Abilities
- Excellent written and verbal communication and interpersonal skills with ability to work with personnel at all levels of the organization
- Good organizational skills and detail oriented
- A working knowledge and awareness of general laboratory procedures
- Ability to comprehend and apply applicable government regulations
- Displays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine
- Ability to work independently and follow written instructions
- Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint)
Performance Requirements
General
- Ability to read, write, speak and understand oral and written instructions
- Available for occasional business travel
Physical Activity
- Requires moderate physical activity including:
- Standing and/or walking for four (4) or more hours per day
- Repetitive movement of hands and fingers
- Reaching and heavy lifting (up to 501bls)
- Prolonged periods of sitting and computer work
- May require transit between buildings or sites as well as walking over rough terrain
Working Conditions
- Work is normally performed in an office or laboratory environment
- May require use of Personal Protection Equipment (PPE) including latex or nitrile gloves, dust mask and/or respirator, safety glasses and PPE, as required
- Work may involve moderate exposure to elements such as dust, fumes, animal dander and/or moderate noise levels
- May involve exposure to hazardous chemicals as well as biohazards
- TB testing required at some sites (negative Mantoux TB test or chest x-ray)
Responsibilities and Duties
Corporate
- Demonstrate Inotiv Core Values
- Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
- Maintain confidential information
General
- Interact with clients, other employees, and the community in a professional manner
- Support and participate in company initiatives as directed
- Maintain thorough knowledge of facility SOPs, policies, study protocols, etc.
- Adhere to all safety regulations and procedures
- Provide assistance or support to other Inotiv QA team members as necessary
- Perform other duties as assigned
Specific
- Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations (audits may include direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, or review of facility records and SOPs as well as subcontractor contributions)
- Prepare an audit report and submit all findings to Study Director/Principal Investigator and management promptly
- Issue accurate quality assurance statements for inclusion in final reports.
- Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC.
- Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs
- Participate in process or facility inspections, as assigned
- Assist with audits and inspections conducted by Sponsors and regulatory agencies as requested
- Support training of other employees and provide guidance on regulatory topics as requested
- Perform other duties as assigned.
The pay range estimated for this position is $26.44 - $36.20 per hour. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
*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 will 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.
Salary will be commensurate with experience and responsibilities. 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.
