Overview of Position: The Quality Assurance (QA) Specialist will report to the Vice President, Quality Assurance & Regulatory Affairs and IO, to assist in providing a critical interface between the scientific community, training activities and research support, ensuring in accordance with federal, state, local and institutional requirements. The QA Specialist will serve as a liaison of the Institutional Animal Care and Use Committee (IACUC), assisting the IACUC Chair, assuming an administrative and professional role that will require continuous contact with individuals at all levels of the organization on a variety of complex issues.
- Conducts post-approval monitoring of rodent behavioral and technical procedures in alignment with approved IACUC protocols in an AAALAC International accredited facility, conducts in-life QC inspections of study test procedures for compliance and conformance to the approved IACUC protocol, the final study plan, and SOPs.
- Performs audits of study specific and facility related documents such as study plans, study raw data, and final report audits for accuracy and completeness, verifies that the final report accurately reflects the raw data generated.
- Serves as IACUC Coordinator; supports and assists the IACUC Chair with the direct oversight of the protocol review and approval process, provides administrative support to the Committee, and accurate and timely IACUC correspondence.
- Receives IACUC protocol and amendment submission from the scientific staff providing initial reviews for accuracy, completeness and compliance with company policies, Institutional requirements, and State/Federal regulations prior to submission to the IACUC.
- Prepares and distributes meeting agendas and compliance related materials for committee review, oversees the recording and production of official minutes of all IACUC meetings, performs editorial review of minutes to ensure proper documentation of IACUC actions, maintains current IACUC policies and protocol documents in the company files and in the IACUC data manager system, oversees training documentation of staff’s protocol and SOP review.
- Conducts inspections of facilities, vivarium, and laboratories, evaluates current practices and procedures. Coordinates and participates in IACUC semi-annual facility inspections, assists in preparation of inspection records, and evaluation of current practices and procedures.
- Reviews and maintains up-to-date SOPs and controlled documents, oversight of SOP Manager system, participates in training activities, conducts audits of employee training records.
- Promotes company polices and operating procedures to maintain a compliant and safe work environment.
- Maintains a current awareness of EPA, FDA, Good Laboratory Practice (GLP) regulations, and any other related NJ state and Federal regulations which may apply to company activities.
- Other duties as assigned by QA management.
- Bachelor’s Degree in Biological or Life Sciences, or related field, or Associate Degree in Veterinary Technology, with at least 3 years relevant IACUC and/or professional experience in animal research, or veterinary medicine, or a Master’s Degree with at least 2 years of work experience.
- Working knowledge of AAALAC standard, PHS OLAW, and AW regulations, federal regulations, and state laws related to IACUC and animal welfare, governing live animal research. Familiar with EPA, FDA, GLP regulations and commonly used concepts , practices and procedures within the QA field specific to preclinical rodent research.
- Ability to follow verbal and written instructions, to work under supervision, to work independently with minimal supervision, and to work effectively as a team member.
- Focused and well-organized with strong attention to detail. Good problem-solving skills and ability to multi-task.
- Familiarity with animal research protocols, post approval monitoring and IACUC procedures.
- Must possess the ability to read and understand scientific documents such as animal research protocols, regulations and policies. Must be able to record and maintain essential records for a regulated environment.
- Effective verbal and written communication skills, excellent interpersonal, collaborative and customer service skills including the ability to interact effectively with a diverse constituent population.
- Proficient computer skills including MS Office applications, MS Word, Excel, Outlook and data manager systems.
- Essential to display sensitivity to the confidential nature of IACUC and QA work. Ability to function in a fast-paced, high growth work environment, exercise good judgment and possess a positive attitude.
- Must be able to wear appropriate personal protective equipment (PPE), as integral to this role will be scheduled visits to areas and the facilities where IACUC approved activities occur.
- AALAS certification at a LAT (Laboratory Animal Technician) or higher level.
- Certified Professional in IACUC Administration (CPIA) certification.