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Thermo Fisher Scientific QC Technical Writer II in Lexington, Massachusetts

Job Title: QC Technical Writer II

Requisition ID: 167318BR

When you are 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.

Location/Division Specific Information

Viral Vector Services (VVS) at the Lexington, MA Facility

How will you make an impact?

The QC Technical Writer II is responsible for investigations including deviations and excursion investigations, initiating and driving change controls to completion, driving process improvement within the QC space, creating and implementing document changes, and authoring complex protocols related to QC Microbiology testing and deliverables. The QC Technical Writer II provide QC microbiological leadership, guidance and support throughout the Thermofisher Scientific site (e.g. projects, product transfers, regulatory inspections).

What will you do?

  • Initiate and drive change controls to completion

  • Facilitate completion of risk assessment(s) as required for change controls and/or as needed to understand and mitigate risk

  • Investigate deviations of varying complexity, identify root cause, and implement appropriate CAPA

  • Author/process change revisions for controlled documents such as standard operating procedures (SOP)

  • Author complex protocols related to environmental monitoring, bioburden testing, method verification, in-situ studies, etc.

  • Support QC and manufacturing personnel in the identification of microbiological root cause analysis.

  • Defines complex issues; recommends and guides implementation of functional strategies across the team

  • Provides frequent overall departmental feedback to senior management.

  • May participate in inspections for regulatory/internal/customer

  • Assist with developing solutions to variety of problems of moderate scope & complexity. Refers to policies & practices for guidance.

Education

Requires BS in Microbiology or related life sciences discipline

Experience

At least 3-5 years of relevant experience within the pharmaceutical or biotechnology industry.

  • Experience with execution of change controls

  • Experience with risk assessment

  • Experience with investigations of deviations and microbial excursions

  • In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.

Knowledge, Skills, Abilities

  • Has good technical understanding and application of principles, concepts, practices in the area of microbiology.

  • Ability to communicate at all levels and across various functions

  • Handle issues appropriately and with a sense of urgency

  • Flexible to meet changing demands to support manufacturing activities.

  • Frequent use & general knowledge of industry practices, techniques and standards.

  • Strong interpersonal and communications skills; written and oral.

At Thermo Fisher Scientific, each one of our 70,000 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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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