Quality Assurance Auditor IIIInotiv • Rockville, MD, United States
Quality Assurance Auditor III
Inotiv • Rockville, MD, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 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 Advanced knowledge of regulatory framework and interpretation and application of regulations Understands business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint) Ability to comprehend and apply applicable government regulations Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions Experience with quality systems management and enterprise quality management software preferred Lean / Six Sigma certification or other process improvement-related experience preferred Ability to read, write, speak and understand oral and written instructions Available for occasional business travel Requires moderate physical activity including : Repetitive movement of hands and fingers Reaching and heavy lifting (up to 50lbs) Prolonged periods of sitting and computer work May require transit between buildings or sites as well as walking over rough terrain 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) Demonstrate Inotiv Core Values Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures Maintain confidential information 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 Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance 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 Demonstrate solid knowledge of 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 Actively participate in managing quality program to ensure compliance with regulatory requirements and serve as a resource for staff on regulatory topics. Support and / or participate in quality assurance inspections from existing or potential clients and regulatory agencies. Assist with managing responses including provision of corrective and preventive actions as assigned. Conduct site- specific and corporate quality training for new hires and other employees, as assigned. Champion the development of standard Quality policies, procedures, job aids and training documents. Support investigation and CAPA activities to ensure elimination or mitigation of quality issues and risks. Apply problem solving methodology including root cause analysis to situations where data suggest process is not operating effectively or variability exceeds expectations. Participate in or lead subcontractor and / or vendor evaluations Participate in equipment and software validation efforts. Serve as a resource to represent the QA team on regulatory topics (e.g, at study initiation meetings), as requested Participate in departmental business, process or general regulatory projects, as assigned The starting salary for this position is $80,100. Salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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.
Position Requirements
Education and Experience
- B.S. in chemistry or life sciences or Bachelor's degree or higher in a related field and
- Three to five years of experience in a GLP preferably with 1-3 or more years of auditing experience, or
- Equivalent combination of education and regulatory, quality, compliance and / or industry experience.
- RQAP-GLP certification preferred.
Skills and Abilities
Performance Requirements
General
Physical Activity
Standing and / or walking for four (4) or more hours per day
Working Conditions
Responsibilities and Duties
Corporate
General
Specific
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.
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