Quality Specialist III, QA Ops

Job description

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply. We offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Location/Division Specific Information

"Thermo Fisher Scientific - Viral Vector Services (VVS)" is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

This candidate will work primarily on site at VVS Somerville MA site and may be expected to routinely travel to the Cambridge location.

How will you make an impact?

The Specialist III, QA is responsible for the quality oversight of VVS Supply Chain Operations at Somerville, MA. This candidate will report to Manager, QA and will work closely with internal partners including but not limited to Supply Chain, Quality Control, Compliance and Quality Systems.

What will you do?

• Provide quality oversight and support to VVS Supply Chain Operations at Somerville, MA to ensure compliance during daily operations.
• Provide QA support and guidance for material specifications, change controls, investigations and CAPAs. Responsible for generating performance metrics, trends.
• Participate in compliance walkthroughs and help drive the closure of any issues. Escalate issues with urgency and propose solutions to resolve the issue(s) in a timely manner.
• Support, as applicable, meetings focused on quality items, material-related projects, day to day GMP oversight and client related topics.
• Participate and provide support for driving continuous improvement in the quality function.
• Participate in inspection/audit readiness and support activities.
• Participate in the supplier management process and activities.
• Document work clearly, accurately, and in accordance with cGMP.
• Flexible to meet changing demands to support manufacturing activities.
• Complete tasks where judgment is required in resolving problems & making recommendations.
• Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner.
• Perform other duties as assigned.
• Travel: ≤ 10%

How will you get here?

EDUCATION

• A minimum of a Bachelor's Degree is required in Chemistry, Life Sciences or Engineering. Equivalent combination of education, training and relevant work experience may be considered.

EXPERIENCE

• At least 5 years of related experience in the Quality Unit.

• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience with key elements of the Quality system including change control, deviations and CAPA.
• Experience with network-based applications such as SAP, TrackWise, is preferred.
• Experience in writing, reviewing and approving GMP documents such as SOPs, Directives, etc.
• Strong organizational and time management skills. Prioritization and problem-solving skills.
• Strong knowledge of Quality procedures, processes and guidelines.
• Experience leading conversations with customers (internal and external).
• Strong interpersonal and communications skills; written and oral.
• Understanding of applicable regulatory requirements.
• Direct experience interacting with agency auditors is preferred.

Knowledge, Skills, Abilities

• Strong understanding of global regulations pertaining to GMPs (particularly US, EU and Japan).
• Ability to work effectively across sites and partner with key internal stakeholder and external suppliers.
• Effective interpersonal and presentation skills.
• Effective oral and written communication skills.
• Strong analytical and organizational skills.
• Ability to multi-task and meet deadlines in a fast-paced environment.
• Strong time management skills and the ability work well in teams, as well as independently.
• Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment and read materials for prolonged periods of time; ability to site, reach with hands and arms, talk and hear others for a prolonged period of time.