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Job DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location/Division Specific InformationThis position will be site based in Lexington, MA and will support our Viral Vector Services (VVS Lexington) business unit of Thermo Fisher Scientific. At VVS Lexington, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies.How will you make an impact?QA Operations provides Quality Assurance support for all areas within ThermoFisher Scientific Lexington facility that are directly or indirectly involved in the execution of Good manufacturing Practices (GMP)-related activities for both clinical and commercial products. This individual will interface closely with other cross-functional groups such as Operations, Facilities, Engineering, QC and Quality. The role will perform record/label issuance to support Manufacturing and Quality Control operations. The individual will perform activities in support of production while ensuring compliance with ThermoFisher Scientific directives and procedures, customer requirements, and regulatory standards.What will you do?
Issuance of GMP documents/label generation to support record and/or label issuance of solution prep, bulk drug substance, drug product and Quality Control.
Interact with internal customers at all levels to support production schedules and provide required documents/labels prior to date needed.
Process workflows in EDMS to support all departmental needs for GMP documents.
Manage the Archive process for Lexington site.
Participate in functional area reviews and ensure departments focus on continuous improvement
Work effectively with people, including good investigation, problem solving and organization skills.
How will you get here?Education
BS/MS in Biology or related science field required.
Experience
4 years experience in a cGMP manufacturing or QA Operations environment, or highly regulated environment with strong knowledge of GMP operations and regulations required.
Experience in supporting GMP operations and systems in a new facility is helpful, in addition to experience in cell or gene therapy.
Experienced in record/label issuance and manufacturing operations preferred.
Knowledge, Skills, Abilities
Skilled in use of Microsoft Outlook, Powerpoint, Word, TrackWise, LIMS, Excel and GMP system programs and spreadsheets.
Ability to work in a fast-paced team environment.
Must be self-motivated, have excellent quality and organization skills and be detail oriented.
Proficient in cGMPs applicability and decision making.
Ability to work effectively with people and communicate challenging information and obtain positive results.
Ability to work cohesively with all departments to ensure strong team communication.
Excellent written and verbal communication skills.
Must have attention to detail and good investigation, problem solving and organizational skills.
Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects/tasks to completion.
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.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.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.
Full-time