Lead QA Technician - 1st Shift

Work Schedule

Environmental Conditions

Job Description

1st Shift - Monday to Friday 8:00AM to 5:00PM

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.

DESCRIPTION:
Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

REQUIREMENTS:
• 4 years of experience in pharmaceutical quality assurance or related GMP environment

• Highschool diploma or GED is required 

• Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field
• Assure all activities are in accordance with the batch records, departmental SOPs, GMP and DEA regulations
• Conducts critical reviews of GMP documentaion associated materials control
• Review of online batch records in terms of completeness of signatures, entries, and material reconcilliation
• Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)
• Approves and controls labels, CoA and CoC product documentation
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Works closely together with pharmacists to gain overall protocol desirables for clinical trial studies
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Ability to work various shifts as required
• Knowledge of root cause analysis and quality improvement tools
• Review CoA and CoC documents and required elements
• Reviews documents completed by operations personnel
• Ability to understand and interpret technical procedures and specifications

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A 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 paid time off (PTO), 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

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards