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Quality Specialist Iii

3 months ago

Columbus, Ohio, United States Thermo Fisher Scientific Full time

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.


Location/Division Specific Information:

This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. Reports to the Franklin, MA site.

Work Schedule:

  • 8:00AM to 5:00PM core hours, additional hours as required.
  • Requires ability to travel on a regional or national level to support the needs of the business 5% of the time.

Discover Impactful Work:


The QA/QC Specialist is responsible for driving the day-to-day GMP Quality Control and Quality Assurance activities for the Franklin MA Commercial site and ensures site level compliance.

This position supports the continued development of GMP capability and maintenance of compliance to US FDA Quality System Regulations and performs site level Quality Control activities.

Also works closely with the Maryland QA/QC Managers to ensure consistent Quality Control activities among sites.

A Day in the Life:

  • Conduct Quality Control inspections and reviews of Operational activities such as receiving, shipping and inventory.
  • Assess for suitability, components and products and approval or rejection of incoming materials, inprocess materials and drug products
  • Ensure that quality documents, protocols and records are current, accurate and properly utilized.
  • Oversight which ensures that developed procedures and specifications are appropriate and followed
  • Monitor Operational Quality: Through consolidation of key quality characteristics of processes, trend analysis and reporting through the Quality Assurance dashboard for identification of satisfactory and/ or unsatisfactory trends and conditions, as well as monitoring resolutions to result in systematic prevention of defects and nonconformances
  • Manage Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan.
  • Ensuring necessary qualification, reviewing resource needs with other functional managers for the benefit of the overall organization.
  • Conduct site level audits.
  • Conduct internal audit and supplier vendor audits, as necessary.
  • Support the maintenance of a competencybased training program.
  • You may be required to support other VVS MA sites as needed.

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 required.

Experience:

  • 3 years of experience in a GMP or similarly regulated facility with a BS degree preferred.
  • 45 years of GMP or similarly regulated facility without a degree required.
  • 3 years cGMP handson experience in Quality arena is required.
  • Requires knowledge of software compliance (21CFR; Part 11).

Knowledge, Skills, Abilities:

  • Effective communication skills are required, both written and verbal.
  • Problem solving skills are required in situations that are not procedurally managed.
  • Ability to handle multiple tasks while ensuring timely and accurate completion.
  • Ability to work independently.
  • Knowledge of cGMPs for medical devices or pharmaceuticals.
  • Strong attention to detail/follow up.
  • Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.

Work Conditions/Physical Requirements:

  • Must have 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.
  • Must use personal protective equipment and adhere 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 walkin freezers or refrigerators periodically for up to 5 hour per day.
  • Must be able to use a computer up to 6 hours per day.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific