Quality Specialist II

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 youll 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 worlds 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 this role youll ensure compliance with GMP standards FDA regulations and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams youll 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:

Bachelors 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 $67400.00$101150.00.

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 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: Experience:

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