Vacancy caducado!
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 Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital 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.Discover Impactful Work:As the QA operations technician, this position will support quality execution across the operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for the Plainville manufacturing facility. Additionally, quality will provide guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.A Day in the Life:
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as the need arises by site procedures and cGMPs.
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance.
Develops quality environment by aiding personnel in understanding application of policies and controls.
Participates in rapid response of adverse events, provides quality guidance for deviation events and proliferate deviations.
Performs quality review and approval of procedures, training documents, deviations, CAPAs and change control and forms minor to major impact.
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity.
Performs quality batch record and documentation review.
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.
Keys to Success:Education
Bachelor’s degree, preferably in technology, engineering or microbiology related field preferred.
Equivalent combinations of education, training, and other relevant work experience in lieu of degree.
Experience
Minimum 4 years of experience in Quality Assurance or Quality control or Operations/Manufacturing or similar regulated environment required.
Knowledge, Skills, Abilities
Ability to collect data, analyze & troubleshoot process issues, equipment problems along with production leadership.
Ability to troubleshoot process and equipment issues.
Self-motivated, proven ownership & responsibility.
Ability to support team/peers.
Technical Writing experience preferred.
Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.
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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.
Vacancy caducado!