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.This position is required to provide comprehensive technical support and quality assurance oversight to maintain site compliance with GMP standards. Support functions which include, but are not limited to, documentation review, supplier management, process monitoring, change control, client relations and Quality Assurance. This role will interface closely with other cross-functional groups such as Operations, Maintenance, Engineering, R&D, Business Management and Quality.LocationBohemia, New YorkDiscover impactful work :As part of the Quality Assurance Team you will assure the quality of current and future products and satisfy the very high expectations of our customers in pharmaceutical manufacturing. You will achieve this by collaborating closely with other functions and departments to determine solutions for diverse challenges as well as independently striving for continual improvement of Quality Management System processes.A day in the life:
Continually improve required Qualifications, Validations and Risk Management activities
Ensure Quality Agreements with clients are established and maintained
Participateinthe site’s continuous improvement projects, PPI
Develop and report metrics related to CLS Quality compliance and present to Senior management on a scheduled basis.
Support site Data Integrity Initiatives
Assist in taking part in the internal audit program.
Lead the completion of action items associated to investigation reports related to compliance actions.
Establish new procedures and update existing ones as appliable.
Support review and implementation of corporate and division policies.
Maintain site compliance with GxP’s as related to US and EU clinical labelling
Review all Quality Agreements and work with Client Services to ensure requirements are included in all client specific profiles.
Support quality on the Change Control Committee
Support the routing and approval of client Change Notifications
Assist quality team as needed with any issues related to Global TrackWise or Documentum
Provide support for site Documentum and Global TrackWise
Other duties may be assigned to meet business needs.
Keys to success:EDUCATIONBachelor's Degree in related area.Experience
Knowledge ofQualityManagement Systems with at least 2 years of experience
Experienced in working in project teams
Knowledge of directives (EU-GMP, US FDA 21 CFR)
Knowledge, skills, abilities
Structured and very diligent working style including ability to organize yourself independently
Analytical skills with provenability to troubleshootcomplex problems
Stronginterpersonalskills to work as a member of a team and collaborateeffectively with other Teams and Functions
Intermediate level skill in Microsoft Word, Excel, Outlook, and other office software programs.
Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Experience with Electronic Quality Management Systems, and electronic signature process compliant to FDA’s Part 11 for electronic records
Physical Demands:
Ability to function in a dynamic environment and balance multiple priorities simultaneously.
Ability to learn new software and tools quickly.
Ability to make decisions and work with minimal to moderate supervision.
While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.
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.Compensation and BenefitsThe salary range estimated for this position based in New York is $70,000.00–$88,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsThermo 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.