Quality Assurance Specialist- Hybrid

AllSTEM Connections; Rahway (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A reputable QA organization is seeking a Quality Specialist with strong animal health GCP and GLP auditing experience. The role involves conducting audits, reviewing bioanalytical studies, and ensuring compliance with regulatory standards. Strong communication and organizational skills are essential, along with at least 5 years of experience in the field. This position offers a hybrid work model, requiring three onsite days per week in Rahway, NJ.

Qualifications

• 5 years of related experience in a regulatory compliance environment.
• At least 2 years auditing experience.
• Ability to work in a multi-task environment.

Responsibilities

• Conduct GLP/GCP study and facility audits.
• Issue and track audit reports.
• Review bioanalytical studies and audit GLP data.

Skills

Animal health GCP auditing

Animal health GLP auditing

Strong communication skills

Organizational skills

Writing skills

Knowledge of VICH GCP Guidelines

FDA bioanalytical method validation

Education

Bachelor’s degree

Job description

Looking for animal health GCP auditing experience. • Animal health GLP auditing experience.

Job Title: Quality Specialist- II -Hybrid Job

Location: Rahway NJ

Duration: 2 years

Provide QA oversight for a Global Research & Development organization. Serve as the Quality Assurance Unit (QAU) in compliance with VICH GL9 (GCP), FDA 21 CFR Part 58, and EPA 40 CFR Part 160 (GLP).

Key Responsibilities

• Conduct GLP/GCP study, facility, data, and report audits (internal & external)
• Issue and track audit reports; ensure resolution of findings
• Review bioanalytical studies (LC/MS-MS preferred); audit GLP data in LIMS systems
• Audit CROs supporting GCP/GLP studies
• Support FDA, EPA, and corporate inspections
• Review and develop SOPs; ensure regulatory compliance
• Provide GLP/GCP training and workload reporting to management

Strong knowledge of FDA bioanalytical method validation guidance required

Description

SCOPE MEASURES

• This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, EPA, and international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.
• This position is required in assuring MAH research meets or exceeds all relevant government and company compliance regulations and standards.

BACKGROUND REQUIREMENTS

• Bachelor’s degree with 5 years related experience, with at least 2 years auditing experience in the regulatory compliance environment,
• Must have strong communication, organization and writing skills.
• Knowledge of VICH GCP Guidelines, FDA, EPA and OECD GLPs.
• Ability to perform in a multi-task environment; ability to facilitate and/or lead a variety of meeting formats.

Note

• Hybrid 3 days onsite - (Tuesday and weds onsite core days, choice of Monday or Thursday for third onsite day)