Quality Specialist II, Lot Disposition

Company: Life Technologies
Location: Cambridge
Posted on: March 15, 2023

Job Description:

Cambridge, MA - Reporting to the Head of QA Lot DispositionHow you will make an impact?The Quality Assurance Lot disposition professional will be a point of contact for the customer on all matters related to Quality Assurance Lot Disposition. 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 while ensuring compliance with Thermo Fisher directives and procedures, customer requirements, and regulatory standards!What will you do?--- Provide quality expertise and oversight of the batch disposition process.--- Responsible for compilation and review of batch release documentation packages.--- Works collaboratively with manufacturing and cross-functional partners to ensure deliverables are met to support disposition.--- Represent the organization and act as SME during external (client and regulatory) inspections as needed--- Responsible complaint investigation and resolution.The QA Lot Disposition professional is responsible for oversight of lot disposition at the Cambridge facility. This individual will work closely with the Quality Operations team to ensure timely and compliant release of batches. The incumbent must be a strategic thinker, excellent communicator, collaborative and possess the ability to make sound, time-sensitive decisions in support of the operations.How you will get here?Education/Experience--- Bachelors degree required with 2 years experience in a GMP environment.Knowledge, Skills, Abilities--- Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.--- Experience with Quality oversight of batch disposition.--- Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal and leadership skills.--- Possesses outstanding time management and multi-tasking abilities to meet commitments and target dates.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 global team of 90,000 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.Job CategoryQualityThermo Fisher Scientificis 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.

Keywords: Life Technologies, Cambridge , Quality Specialist II, Lot Disposition, Other , Cambridge, Massachusetts