Quality Specialist III

Thermo Fisher Scientific•Franklin, MA

16d•Onsite

About The Position

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, in-process 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 non-conformances · 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 competency-based training program. · You may be required to support other VVS MA sites as needed.

Requirements

High school diploma or equivalent required.
3 years of experience in a GMP or similarly regulated facility with a BS degree preferred.
Minimum 4 years of GMP or similarly regulated facility without a degree required.
3 years cGMP hands-on experience in Quality arena is required.
Requires knowledge of software compliance (21CFR; Part 11).
Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
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 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/follow up.
Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.
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 walk-in freezers or refrigerators periodically.
Must be able to use a computer up to 6 hours per day.
Must be legally authorized to work in the United States now or in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening

Nice To Haves

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

Responsibilities

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, in-process 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 non-conformances
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 competency-based training program.
You may be required to support other VVS MA sites as needed.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits!
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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

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