Junior Quality Assurance Specialist

Job Description

Job DescriptionSalary: $68,000 - $72,000

Junior Quality Assurance Specialist |Clinvet NY | Waverly, NY

About Us

Clinvet NY is a global veterinary contract research organization (CRO) specializing in invitro, pre-clinical, and clinical trials to evaluate the safety, metabolism, and efficacy of animal health products. As part of the Clinglobal Group, we support innovation for animal health companies worldwidefrom startups to industry leaders.

Position Overview

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.

Key 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.

Qualifications & Experience

• Bachelors 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.

Skills & Competencies

• 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.

Physical Requirements

• Ability to sit, stand, and walk for extended periods
• Ability to lift and carry 5075 lbs.
• Ability to work 8-hour shifts in varying weather conditions (heat, cold, noise)
• Ability to perform duties in physically demanding and occasionally high-stress environments

Compensation & Benefits

• $68,000 $72,000 / year
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off with increasing accrual over time

Additional Information

• Our facility is USDA-licensed and AAALAC-accredited
• Applicants must apply using a supported browser (Internet Explorer is not supported

Equal Opportunity Employer

Clinvet NY is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment of any kind in accordance with applicable laws.

Data Privacy Notice

Clinvet NYcomplies with all applicable data protection and privacy laws. By applying, you consent to the processing of your personal information in accordance with our recruitment procedures and Privacy Notice.