Product Complaints Investigator II - Medical Device

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

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

Job Description

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.

As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through commercialization.

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

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.

Discover Impactful Work:

The Product Compliant Investigator II supports the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment. This role contributes to maintaining compliance with cGMP requirements while protecting product quality and patient safety.

Working under general supervision, you will execute complaint investigations of low to moderate complexity, collaborate with cross-functional teams, and develop foundational expertise in complaint handling, root cause analysis, and quality systems.

A Day in the Life:

• Perform product 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.
• Assist with audits, inspections, and customer inquiries.
• Maintain compliance with safety and quality requirements.
• Manage workload while meeting timelines and quality expectations.
• Perform other duties as assigned.

Keys to Success:

Education

Associate’s or Bachelor’s degree in health science, life science, engineering, or related discipline and a minimum of 4 years of work experience

Experience

• Minimum of 4 years of experience within combination products or medical device industry
• Experience conducting GMP investigations involving combination product or medical device complaints, deviations, or quality events strongly preferred .
• CDMO or manufacturing experience is a plus.

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.

Physical Requirements / Work Environment

• Requires standing, walking, lifting up to 35 pounds, manual dexterity, prolonged computer use, and ability to work in office/manufacturing environments.