Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Discover Impactful Work

At Thermo Fisher Scientific, we believe in creating a healthier, cleaner, and safer world. As a QA Technician in our Clinical Trials Division, you will play a vital role in ensuring our products meet the highest quality standards, contributing to impactful global projects and advancing your career.

A Day in the Life

As a QA Technician, your responsibilities will include:

• Supporting the completion and documentation of batch records, memos, and related materials.
• Coordinating the storage and retrieval of all batch records from archives.
• Maintaining up-to-date database records related to batch record review, storage, and archival.
• Assisting in routine archiving and destruction of outdated records.
• Managing document storage and generating approved record copies for clients upon request.
• Documenting trends related to error classification, root causes, turnaround times, and outstanding records.
• Coordinating Standard Operating Procedures (SOPs), Work Instructions (WIs), and Forms.
• Collecting and analyzing quality data, running Trackwise queries, and preparing quality reports.
• Managing new or updated documentation from date stamping to filing.
• Developing and updating QA documentation, Pack-Out procedures, and work instructions.
• Creating, issuing, retrieving, reviewing, and archiving log books.
• Interpreting Quality Assurance standards to outline department policies and procedures.
• Supporting training for new colleagues in QA documentation and Pack-Out processes.
• Participating in investigations, audits, and drafting responses for audit observations and CAPAs.
• Assisting with Pack Out and QA Final Release on a regular basis.
• Participating in GEMBa & JDI walks
• Performing additional duties as assigned to meet business needs.

• Associate's or Bachelor's degree required.

• 2+ years of related experience in cGMP and/or Quality Assurance is required.
• Experience in a GMP environment is preferred; equivalent experience may be accepted in lieu of a degree.

• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint) with a willingness to learn new software.
• Strong written and verbal communication skills.
• Excellent organization, planning, multi-tasking, and time management skills.

• Position requires ordinary ambulatory skills and coordination to navigate office environments.
• Ability to stand, walk, stoop, kneel, and crouch for extended periods.
• Capability to manipulate light to medium weights (10-35 pounds).
• Arm, hand, and finger dexterity for prolonged typing and grasping tasks.
• Visual acuity for using a keyboard, operating equipment, and reading materials.
• Ability to sit, reach, talk, and hear for extended durations.
• Commitment to adhering to Occupational Health and Safety policies to maintain a safe and healthy workplace.

• 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