Senior Quality & Compliance Specialist

Thermo Fisher; Ridgefield (NJ); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Vision plan

Employee assistance programs

Paid time off 120 hours

Job summary

Thermo Fisher Scientific seeks a Quality Assurance Representative to maintain our quality systems and regulatory compliance across the New Jersey facility. You will oversee CAPA, deviations, investigations, change control, and supplier qualifications while ensuring audit readiness.

You will train staff on cGMP regulations and collaborate with internal and external partners to uphold product quality. Join a global team delivering solutions that help make the world healthier, cleaner and safer.

Qualifications

• Advanced degree with 2+ years of experience, or Bachelor's with 5+ years in science.
• Strong project management and problem-solving abilities.
• Excellent written and verbal English communication skills.
• Ability to work independently and in a matrix environment.
• Proven track record of building supplier and interdepartmental relationships.

Responsibilities

• Maintains Change Control, Deviation, OOS, CAPA, complaints and investigations follow-up.
• Establishes and maintains SOPs; periodic reviews to align with regulatory requirements.
• Audits departments for compliance and generates audit reports.
• Oversees supplier qualifications, quality agreements, and audit schedules.
• Maintains facility compliance status and audit readiness.
• Implements quality compliance and corrective action training.
• Trains new employees on TFS procedures and cGMP regulations.
• Works independently on projects as QA Representative with minimal supervision.
• Maintains current knowledge of ICH requirements for quality systems.
• Generates, reviews, and submits APQRs with oversight.
• Partners with site logistics and QA and network resources on supplier issues.
• Participates in cross-functional process improvement initiatives to enhance client satisfaction.
• Performs other assignments as required.

Skills

Project management

Problem solving

Communication skills

Independent work

Matrix collaboration

Supplier relationship management

Education

Advanced degree or Bachelors in Chemistry/Biology or related

Job description

Thermo Fisher Scientific seeks a Quality Assurance Representative to maintain our quality systems and regulatory compliance across the New Jersey facility. You will oversee CAPA, deviations, investigations, change control, and supplier qualifications while ensuring audit readiness.

You will train staff on cGMP regulations and collaborate with internal and external partners to uphold product quality. Join a global team delivering solutions that help make the world healthier, cleaner and safer.