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Quality Specialist II Night Shift

Company: thermo fisher scientific
Location: Cambridge
Posted on: November 23, 2021

Job Description:

When youre part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals. Location/Division Specific Information This position reports into the Cambridge, MA site of Viral Vector Services (VVS) and reports to the QA Ops Supervisor. How will you make an impact? The Quality Assurance Specialist II 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 VVS directives and procedures, customer requirements, and regulatory standards. Hours: Rotating 2/2/3 Night Shift 7:00PM-7:00AM What will you do? Responsible for contributing to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with CAPA, deviations, and other documentation related to MFG and QA operations. Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. Provides feedback for personnel development. Batch Record/Logbook review Document/Label Issuance and archival Quality support for Critical MFG Operations on the floor Initiation and approval of deviations through Trackwise Participate in training of personnel Mentor Junior Staff Process improvement initiatives Review and approve documents including: Standard Operating Procedures, Batch Records, Work Instructions. Perform Acceptable Quality Limit (AQL) of Fill Finish vials EM Data review for Room release Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities How will you get here? Education High School Diploma is required Bachelors Degree in Sciences Preferred Experience minimum 3-5 years Quality related experience Solid understanding of US, EU and ROW cGMP guidelines and requirements. Knowledge, Skills, Abilities 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. Strong time management and organizational skills. 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/FACTORS: Ability to function in a rapidly changing environment & handle multiple priorities. A flexible work schedule is required. Ability to lift up to 25 lbs. Specific vision abilities required by this job include close vision, and ability to adjust focus. At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer. Apply today! 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. by Jobble

Keywords: thermo fisher scientific, Cambridge , Quality Specialist II Night Shift, Other , Cambridge, Massachusetts

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