Quality Specialist III

Work Schedule

Environmental Conditions

Job Description

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 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.

Keys to Success:

Education

High school diploma or equivalent required.

Bachelors Degree in Scientific/Technical field or related field (i.e. Chemistry Biology or Engineering) preferred.

Experience

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).

Knowledge Skills Abilities

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.

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 (-78C) or liquid nitrogen (-195C).

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.

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.

OTHER

• Relocation assistance is NOT provided
• 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

Compensation and Benefits

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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