Quality Specialist II

Regulatory Jobs; Franklin (MA); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health and dental plans

Vision plan

Employee assistance program

Tuition reimbursement

Paid time off and holidays

Parental leave

401(k) retirement plan

Employee stock purchase plan

Job summary

Thermo Fisher Scientific is seeking a Quality Specialist II in Massachusetts to ensure GMP compliance and support manufacturing operations across multiple product lines.

You will conduct investigations, drive CAPA and change control, and maintain quality management systems while collaborating with cross-functional teams to deliver high-quality products for global healthcare and scientific advancement.

Qualifications

• Bachelor's degree with minimum 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment.
• Knowledge of cGMP regulations, ISO 9001/13485, and international regulatory requirements.
• Experience with quality management systems and documentation (TrackWise, Master Control, Documentum, or equivalent).
• Experience in deviation investigations, CAPA, change control, and root cause analysis.
• Technical writing and documentation skills; clear verbal and written communication.

Responsibilities

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements.
• Support manufacturing operations across multiple product lines.
• Conduct investigations and lead CAPA, change control, and root cause analysis.
• Maintain quality management systems and documentation; support internal audits and regulatory inspections.

Skills

cGMP regulations

Regulatory requirements

ISO 9001/13485

Analytical thinking

Problem solving

Technical writing

Verbal and written communication

Cross-functional collaboration

Audits & inspections

Project management

Independent work

Gowning & PPE compliance

Warehouse environment

Travel up to 10%

Education

Bachelor's degree in pharma/biotech/QA

Tools

TrackWise

Master Control

Documentum

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

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.

DESCRIPTION

Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

REQUIREMENTS

• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, Master Control, Documentum, 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 supporting internal audits and external regulatory inspections
• Project management and organizational skills
• Ability to work in warehouse environments and follow gowning procedures where required
• Ability to work in a cold environment with exposure to dry ice and liquid nitrogen cryogenics
• Must be able to process and handle materials frozen on dry ice or liquid nitrogen
• Must use personal protective equipment and adhere to safety protocols
• Additional language skills may be beneficial
• Up to 10% travel may be required
• Work schedule 8am-5pm, with additional hours as required
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25lbs

EDUCATION

• Bachelor's degree with minimum 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

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $67,400.00–$101,150.00.

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 (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