Quality Assurance Auditor II
The Quality Assurance Auditor II coordinates auditing activities to ensure compliance with standard operating procedures (SOPs) and good laboratory practice (GLP) requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.
About SNBL USA
SNBL USA is a preclinical contract research organization renowned for its diverse range of safety assessment services and non human primate expertise. With programs in toxicology, radiation biology, exploratory research, pathology and bioanalysis, our teams of scientists are committed to the advancement of novel therapeutics, devices and medical breakthroughs.
How You'll Contribute:
- Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations and internal SOPs.
- Performs phase inspections of ongoing study activities.
- Performs facility audits to ensure departmental compliance with the regulations.
- Oversees and assists with audits to assure departmental consistency.
- Prepares, issues, and tracks reports of observations noted during audits and inspections.
- Applies a thorough understanding of compliance to a broad range of regulatory issues.
- Maintains computerized files to support audit activities.
- Assists in scheduling audits and assigning resources to projects.
- Coordinates auditing activities and implements auditing systems to ensure compliance with GLP requirements.
- Identifies, evaluates, and implements best practices.
- Evaluates interdepartmental processes for improvement opportunities and proposes solutions.
- Helps design and develop risk-managed regulatory processes.
- Oversees and designs training systems; acts as a lead trainer for new and junior staff.
- Drives project planning and implementation; acts as lead auditor on studies.
- Solicits and gains support of employees, clients and management through effective collaboration and negotiation; represents QA in work-groups
- Communicates with clients regarding regulatory issues.
- Performs training of SNBL USA staff by conducting training seminars and distributing information on GLP regulations and other related standards.
- Participates as company representative on client visits and provides assistance with client's regulatory issues.
- Performs support services for non-GLP protocols, study data and draft reports.
- Reviews and updates Quality Assurance SOPs to ensure reflection of current practice.
- Performs vendor compliance audits.Audits analytical or 3rd party studies for consistency and conformance with the regulations.
- Supports client visits and regulatory agency inspections.
- Bachelor's degree (B.S.) in a scientific discipline, or equivalent combination of education and experience.
- Two to three years related technical experience and/or training. Two to three years auditing experience, as an auditor in a GLP-regulated environment.
- Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor) or other certification is preferred.
- Microsoft Office Suite
- Ability to read and interpret documents such as protocols, Standard Operating Procedures, regulations, guidance documents, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak professionally and effectively with clients and staff.
- Working knowledge of basic math skills. Ability to recalculate and analyze mathematical results. Ability to use Excel functions in evaluation of numeric data.
- Training needs for this position include on-the-job training in performing audits and inspections and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.
- Excellent reading, writing, and verbal communication skills. Ability to interpret a variety of written and verbal instructions. Familiarity with Medical Terminology and the language of toxicology, pathology and regulatory affairs. Must have demonstrated ability to train exempt employees and/or skilled non-exempt employees in FDA and OECD GLP regulations and requirements. Proven track record of facilitating positive organizational change working with interdepartmental teams. Works on problems of diverse scope where analysis of data requires evaluation of various factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining results. Knowledge and proficiency in the GLP regulations, preambles, question and answer documents, and guidance documents. Ability to discuss and provide interpretation of these documents to the technical staff. Must regularly exercise discretion and independent judgment.
What We Offer:
- Competitive salary
- Medical/Dental/Vision insurance
- Life insurance
- Relaxed dress code
- Paid holidays
- Paid Time Off
- On-site cafeteria and gym
- Company events, including happy hours, team building competitions, lunches and much more.