Product Compliant Investigator III - 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

• Lead end-to-end product complaint investigations of moderate to high complexity.
• Conduct root cause analysis, risk assessments, and document investigations in compliance with cGMPs and quality systems.
• Evaluate product quality, patient safety, and regulatory impact while escalating critical issues appropriately.
• Serve as a technical and regulatory resource for complaint investigations.
• Partner with Manufacturing, QC, Regulatory, Supply Chain, and customers to resolve complaints.
• Drive timely and effective CAPA implementation.
• Author and revise complaint procedures, work instructions, and investigation reports.
• Support regulatory inspections, audits, and customer audits.
• Manage multiple priorities in a fast-paced manufacturing environment.
• Mentor junior complaint investigators.
• Perform other duties as assigned.

Requirements

• Education: Bachelor’s degree in health science, life science, engineering, or related discipline.
• Experience: Minimum of 4 years of progressive pharmaceutical or biotechnology industry experience. Experience conducting GMP investigations involving product complaints, deviations, or quality events strongly preferred. CDMO and/or sterile manufacturing experience is a plus.

Qualifications

• Knowledge, Skills, Abilities: Strong knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing. Ability to independently assess complex quality issues and risk. Excellent written and verbal communication skills. Strong organizational skills with ability to manage multiple priorities. Excellent documentation and attention to detail. Self-motivated with ability to work independently. Comfortable working in a fast-paced regulated manufacturing environment.

Skills

• Strong knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing.
• Ability to independently assess complex quality issues and risk.
• Excellent written and verbal communication skills.
• Strong organizational skills with ability to manage multiple priorities.
• Excellent documentation and attention to detail.
• Self-motivated with ability to work independently.
• Comfortable working in a fast-paced regulated manufacturing environment.

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

Pay

Not specified

Schedule

Not specified

Benefits

Not specified

Location/Division Specific Information

Greenville, NC
RELOCATION ASSISTANCE IS NOT PROVIDED
Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
Must be able to pass a comprehensive background check, which includes a drug screen.