Junior Quality Assurance Specialist

Clinglobal Group•Town of Barton, NY

1d•$68,000 - $72,000•Onsite

About The Position

The Junior Specialist: Quality Assurance supports the QA function at Clinvet NY by assisting with study-specific audits, system and process audits, controlled document review, CAPA tracking, training compliance monitoring, audit reporting, inspection readiness, and departmental QA administration.

Requirements

Bachelor’s degree or BSc in Animal Health, Veterinary Science, Biological Sciences, Life Sciences, Quality Assurance, Regulatory Compliance, or a related field.
At least 2 years’ relevant experience in a regulated environment such as a laboratory, CRO, animal health research facility, clinical research environment, preclinical research environment, quality system environment, or related regulated operation.
Strong documentation, organizational, administrative, communication, and follow-up skills.
Ability to identify documentation gaps, compliance issues, audit findings, and quality risks and escalate them appropriately.
Experience in animal research, veterinary, clinical, preclinical, laboratory, or contract research environment.
Familiarity with IACUC, animal welfare, biosafety, accreditation, study protocol, and study documentation requirements.

Responsibilities

Support compliance with GLP, GCP, international guidelines, regulatory requirements, applicable legislation, study protocols, study plans, SOPs, work instructions, controlled documents, and facility standards.
Perform or assist with study-specific audits on critical study phases as assigned and within approved training and delegation.
Perform directed audits as requested and delegated by QA leadership.
Prepare audit reports that accurately document audit scope, observations, findings, critical issues, evidence reviewed and required follow-up actions.
Report audit findings, compliance concerns, and quality risks to QA leadership in a timely and professional manner.
Perform reviews of controlled documents as delegated, including SOPs, work instructions, forms, templates, and related quality documents.
Perform duties according to applicable quality guidelines, including GLP/GCP, where relevant, SOPs, work instructions, study protocols, study plans, IACUC/IBC approvals, Animal Care and Use Program requirements, Quality Management System requirements, and sponsor expectations.
Perform duties in compliance with applicable federal, New York State, local, legislative, regulatory, contractual, client, sponsor, and company requirements.
Observe occupational health and safety requirements and comply with PPE, biosafety, biosecurity, site access, and animal care and use procedures.
Identify, document, report, and escalate incidents, maintenance faults, animal welfare issues, biosafety concerns, study deviations, adverse events, documentation gaps, data integrity concerns, and study conduct concerns.
Maintain confidentiality, data integrity, ethical conduct, professional behavior, and work outputs consistent with company and departmental standards.