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Thermo Fisher Scientific Specialist II, Quality - Days in Cambridge, Massachusetts

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Division:

The Viral Vector Services (VVS) Business Unit is part of the Pharma Services Group. VVS provides contract development and manufacturing services to companies seeking to develop and commercialize gene and gene modified cell therapies. Gene therapies are designed to treat diseases by modifying or supplementing genetic information, including correcting genes that function improperly or adding normal copies of defective genes. They have the potential to address and potentially cure a wide range of ailments, including various inherited and acquired diseases such as cancers, Alzheimers, hemophilia, types of blindness, cardiovascular diseases and infections such as HIV.

Location : Cambridge, MA

Shift : Swing Shift - Days (Sun – Wed) 7AM – 7PM

How will you make an impact?

The Quality Assurance Specialist II will be the primary point of contact for the customer on all matters related Quality Assurance Operations. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with VVS directives and procedures, customer requirements, and regulatory standards.

What will you do?

Provide QA support for Client Projects and GMP Operations from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption.

Responsibilities include:

  • Providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.

  • Routinely Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.

  • Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.

  • Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance. Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.

  • Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.

  • Write, revise and approve GMP documentation as necessary.

  • Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner.

  • Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

  • Draft technical plans, reports, and protocols with supervision; Batch Record/Logbook review; Document/Label Issuance and archival

  • Quality support for Critical MFG Operations on the floor

  • Initiation and approval of deviations through Trackwise

  • Participate in training of personnel; Mentor Junior Staff

  • Process improvement initiatives

  • Review and approve documents including: Standard Operating Procedures, Batch Records, Work Instructions.

  • Perform Acceptable Quality Limit (AQL) of Fill Finish vials

  • EM Data review for Room release

  • Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities

How will you get here?

Education: B.S. in Chem Eng, Biochemistry, Biology or related field with 2+ yrs experience preferred; or a Masters Degree in related field

Knowledge/Abilities needed:

  • Solid understanding of US, EU and ROW cGMP guidelines and requirements.

  • Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.

  • Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment

  • Ability to understand operational documents for GMP compliance, accuracy and completeness. Ability to work by influencing a matrix management system and to gain the collaboration of others.

  • Strong client-facing interpersonal skills coupled with a concern for impact.

  • Strong time management and organizational skills.

  • Excellent written and oral communication skills both internal and external.

  • Able to manage multiple priorities and demonstrate self-control

  • Ability to resolve conflict within project teams.

  • Good leadership skills.

  • Strong attention to detail

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Physical Demands/Factors:

Ability to function in a rapidly changing environment & handle multiple priorities. A flexible work schedule is required. Ability to lift up to 25 lbs. Specific vision abilities required by this job include close vision, and ability to adjust focus.

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.

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.

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