Quality Specialist II

Achieve Your Goals

Thermo Fisher Scientific offers a comprehensive benefits package including:

• 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

What You'll Do

Support manufacturing operations through quality oversight, deviation investigations, CAPA management, change control activities, audit support, documentation review, and continuous improvement initiatives.

Partner with cross-functional teams to ensure compliance with GMP, FDA, ISO, and internal quality requirements.

What You'll Need

• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• Preferred fields of study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, MasterControl, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience conducting internal audits and supporting external regulatory inspections
• Project management and organizational skills
• Ability to work in cleanroom environments and follow gowning procedures where required