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Thermo Fisher Scientific QA, Specialist I in Cambridge, Massachusetts

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, and we offer the expertise and resources necessary to help clients deliver innovative gene therapies. VVS is an experienced viral vector CDMO focused on process and analytical development. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need.

The Quality Assurance Specialist 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 Brammer Bio directives and procedures, customer requirements, and regulatory standards.

Essential Responsibilities:

• Providing 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.

• Participates in PPI initiatives.

• Manages projects at the task level under supervision.

• Some interaction, may see clients and present data to clients with supervision

• Responsible for contributing to key functional, tactical, and operational aspects of Thermo Fisher Scientific's operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with exceptions, CAPA, deviations, Analytical instrument validation, change control requests, and other documentation related to Mfg and QA operations.

• Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements, as delegated by management.

• Proficiency in project management, processes, improvement and ability to address through risk assessment.

• Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections.

• Provides feedback for personnel development

12 hour rotating shift from 7pm to 7am.

Knowledge, Skill, and Requirements:

• High School Diploma with 4+ years experience or Bachelors degree in Chemistry Engineering, Biochemistry, Biology or related field preferred

• 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 cooperation of others.

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

• High initiative.

• Rational Persuasion

• Strong time management and organizational skills.

• Pragmatic, proactive yet flexible approach in the working environment.

• 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

• Ability to function in a rapidly changing environment & handle multiple priorities

• A flexible work schedule is required.

• Ability to lift up to 25 lbs.

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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