Product Compliant Investigator II - Medical Device

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

About the Role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Responsibilities

• Support the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment.
• Contribute to maintaining compliance with cGMP requirements while protecting product quality and patient safety.
• Execute complaint investigations of low to moderate complexity.
• Collect, document, and assess data supporting root cause analysis.
• Draft investigation reports for review and approval.
• Escalate quality, regulatory, or patient safety concerns promptly.
• Support CAPA implementation and tracking.
• Partner with Manufacturing, QC, Supply Chain, and cross-functional teams.
• Aid with audits, inspections, and customer inquiries.
• Manage workload while meeting timelines and quality expectations.
• Perform other duties as assigned.

Requirements

• Education: Bachelor’s degree in health science, life science, engineering, or related discipline.
• Experience: 2–4 years of pharmaceutical or biotechnology industry experience. Experience supporting GMP investigations preferred. CDMO or manufacturing experience is a plus.

Qualifications

• Knowledge, Skills, Abilities: Working knowledge of cGMP regulations and quality systems. Strong written and verbal communication skills. Good organizational skills and attention to detail. Ability to manage multiple priorities and meet deadlines. Self-motivated with willingness to learn and develop technical expertise. Works effectively in cross-functional teams.

Skills

Working knowledge of cGMP regulations and quality systems. Strong written and verbal communication skills. Good organizational skills and attention to detail. Ability to manage multiple priorities and meet deadlines. Self-motivated with willingness to learn and develop technical expertise. Works effectively in cross-functional teams.

Benefits

Excellent Benefits Package
Review our company’s Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 5%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities

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