Quality Assurance Inspector

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.

About the role

Join our team at Thermo Fisher Scientific as a Lead QC Technician, where you'll help make the world healthier, cleaner and safer. In this role, you'll ensure quality standards are met through inspection of products in a cGMP environment. The Operations, Clinical Quality Assurance Inspector will support all Quality functions related to packaging activities of clinical product processed through primary and secondary packaging operations, including support of commercial packaging activities. The role involves supporting management and the quality team with close interaction across functional groups at the site. You will problem-solve to ensure the site follows established quality systems and require strong verbal and written communication skills.

Responsibilities

• Apply Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Demonstrate and promote the company vision.
• Perform approval of specifications and incoming inspections on material (e.g., drug, components) and distribution shipments.
• Perform material and process inspections and samplings.
• Review and approve Packaging Electronic Production Orders.
• Participate in continuous improvement initiatives and assist with root cause investigations for nonconforming issues.
• Author, revise, and follow all relevant SOPs/Work Instructions and accurately document activities as needed.
• Resolve and escalate issues potentially affecting product quality/compliance to the Team Leader and/or Management.
• Ensure issues are resolved in a timely manner and corrective actions are implemented.
• Perform all activities in a safe and efficient manner.
• Other duties as assigned to meet business needs.

Requirements

• Associate degree preferred; High School Diploma or equivalent required.
• At least 2 years of experience in Pharmaceutical or a related regulated industry.
• Minimum of 1 year of experience in Pharmaceutical or a related regulated industry with a High School diploma.
• Familiarity with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others).
• Ability to work in a refrigerated environment (2° C to 8° C) and freezer environment (-20° C) with provided protective wear.
• Willingness to work various shifts and overtime depending on business needs.
• Ability to work independently.
• Skills to read, understand, and follow SOPs, Work Instructions, and policies in a GMP environment.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• Cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Cold Room/Freezers: -22°F / -6°C.
• No contact lenses allowed; prescription glasses will be provided.
• Required PPE: safety glasses, gowning, gloves, lab coat, ear plugs, etc.

Physical Requirements

• Extensive standing and walking on the packaging floor to monitor room activities.
• Work schedule: 1st shift weekends (Friday - Sunday), 12.5-hour shifts.
• Additional overtime and weekend work may be required.
• Standing, bending, and lifting required: up to 25 lbs occasionally and 10 lbs regularly.
• Exposure to cold temperatures for more than one hour at a time, including -20°F for at least 15 minutes.
• Exposure to atmospheric conditions may require special personal protective equipment.
• Responsible for inspection of pharmaceutical products, components, and labels; must meet visual acuity/color blindness standards for visual inspections in a cGMP environment.

Pay

$23 - $32 per hour

Schedule

1st shift weekends: Friday - Sunday, 12.5-hour shifts.