Sr Compliance Specialist

Thermo Fisher Scientific • Ridgefield, NJ

8d • $29 - $43 • Onsite

About The Position

As part of Thermo Fisher Scientific, the Sr Compliance Specialist contributes to work supporting the company’s mission to enable customers to make the world healthier, cleaner, and safer. The role assists in establishing and maintaining quality systems for investigational new drugs, biologics, and/or medical devices in alignment with industry, regulatory, and customer requirements, and helps maintain operations in a state of control. The specialist also assists the QA Director in maintaining established systems.

The position maintains quality processes and documentation, supports facility compliance and audit readiness, provides quality oversight of vendors and suppliers, and participates in cross-functional process improvement initiatives. The specialist works independently on projects as a Quality Assurance Representative and trains employees and junior team members on company procedures and cGMP regulations.

Requirements

• Advanced degree plus 2 years of experience, or a bachelor’s degree in Chemistry, Biology, or a related scientific discipline plus 5 years of experience.
• Excellent project management and problem-solving abilities.
• Strong written and verbal communication skills in English.
• Ability to work independently and collaborate effectively in a matrix environment.
• Proven ability to build relationships with suppliers and interdepartmental groups.

Responsibilities

• Maintain Change Control, Deviation, Out of Specification, Corrective and Preventative Action, complaint, and investigation report systems, including follow-up actions.
• Establish and maintain Standard Operating Procedures (SOPs), conduct periodic reviews to ensure alignment with regulatory and global requirements, and provide training as needed.
• Audit departments for compliance with quality systems, generate audit reports, identify trends, and assess quality-system performance.
• Provide quality oversight of vendor qualifications, including questionnaires, quality agreements, and vendor audit schedules.
• Assist in maintaining facility compliance status and audit readiness.
• Implement quality compliance and corrective action training.
• Train new employees and junior team members on Thermo Fisher Scientific procedures and cGMP regulations.
• Work independently on projects as a Quality Assurance Representative without supervision.
• Maintain current knowledge of ICH requirements to support quality-system compliance.
• Ensure APQRs are properly generated, reviewed, and submitted.
• Partner with site Logistics and Quality Assurance and network resources to oversee supplier management and site-specific supplier quality issues.
• Participate in cross-functional process control, improvement, and optimization projects, as well as other continuous improvement projects to enhance client satisfaction.
• Complete other assignments and tasks as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior