• Lead Quality Specialist

    ThermoFisher Scientific (Franklin, MA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    Make a Meaningful Impact with Thermo Fisher Scientific

     

    Join a global leader dedicated to delivering innovative solutions to the world's most pressing challenges.

     

    This position is part of the Fisher BioServices business unit of Thermo Fisher Scientific and is based at our Franklin, MA facility.

     

    Work Schedule

     

    Standard core hours are 8:00 AM to 5:00 PM, with flexibility for additional hours as required.

     

    This role includes occasional travel (approximately 5%) on a regional or national level to support business needs.

     

    A Day in the Life

     

    We are seeking a dedicated professional to lead GMP Quality Control (QC) and Quality Assurance (QA) activities at our Franklin, MA site. This role is pivotal in maintaining regulatory compliance and enhancing our GMP capabilities. Be part of a team that strives for excellence and is driven to achieve best-in-class quality standards.

     

    Perform Quality Control inspections and reviews of operational activities, including receiving, shipping, and inventory management.

     

    Evaluate the suitability of components and products, including approval or rejection of incoming materials, in-process materials, and finished drug products.

     

    Ensure quality documentation—including protocols, procedures, and records—is accurate, up to date, and consistently applied.

     

    Provide oversight to ensure procedures and specifications are well-developed and effectively implemented.

     

    Lead process quality initiatives by monitoring trends, identifying root causes, and implementing corrective and preventive actions to minimize defects.

     

    Drive continuous improvement through the development and revision of Standard Operating Procedures (SOPs), management of change controls, and collection of compliance metrics.

     

    Collaborate with cross-functional managers to assess resource needs and ensure proper staff qualification in support of organizational goals.

     

    Conduct internal audits and site-level inspections to ensure compliance with regulatory and company standards.

     

    Perform supplier and vendor audits as required to maintain quality across the supply chain.

     

    Support and help maintain a competency-based training program to ensure team proficiency and regulatory compliance.

    Keys to Success:

    Education

    Bachelor's Degree in Scientific/Technical field, or related field (i.e. Chemistry, Biology, or Engineering) preferred.

     

    High school diploma or equivalent experience required.

    Experience

    3 + years GMP hands-on experience in Quality area is required.

     

    Knowledge of software compliance (21CFR; Part 11) is preferred.

     

    Knowledge, Skills, Abilities

     

    Proficient with personal digital literacy, specifically Microsoft office applications, with the ability to learn new computer systems quickly.

     

    Effective interpersonal skills are required, both written and verbal.

     

    Problem solving skills are required in situations that are not procedurally handled.

     

    Ability to balance multiple tasks while ensuring timely and accurate completion.

     

    Ability to work independently.

     

    Knowledge of the pharmaceutical GMP regulations and their appropriate application to assure compliance with regards to manufacturing problems.

     

    Knowledge of cGMPs for medical devices or pharmaceuticals.

     

    Strong attention to detail.

     

    Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.

    Work Conditions/Physical Requirements:

    Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents and marked changes in temperature.

     

    May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.

     

    Use personal protective equipment and implement to safety protocols.

     

    Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.

     

    Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).

     

    Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.

     

    Use a computer up to 6 hours per day.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.