Quality Control Data Reviewer
Framingham, Massachusetts Permanent Date posted Sep. 10, 2024Position Title: Quality Control Data Reviewer - Quality Control Chemistry
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Your job, as Quality Control Data Reviewer - QC Chemistrywithin our Quality team, will be to provide quality support and guidance of assays to Quality Control Chemistry for release of life-saving products to our patients. You are a valued influencer and mentor who has contributed to QC assay review of a Biologics or Pharmaceutical organization. You have a keen eye for improvement opportunities and the demonstrated ability to deliver on these opportunities using your personal experience.
About the Job:
Quality Control Chemistry is responsible for testing intermediate, finished product, and stability samples in support of Manufacturing for the Massachusetts Bio Campus.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Review QC Data for compliance to procedures, specifications and cGMP.
Review complex QC data in HPLC/UPLC, Gel Electrophoresis, Spectrophotometric assays within multiple laboratory software.
Collaborate on Quality Control method investigation and corrective action implementation.
Maintain laboratory testing files and archive test records and logbooks.
Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections.
Revise procedures for Continuous Improvement.
This is a Monday to Friday, on-site position in Framingham, Massachusetts.
About you:
Bachelor's Degree in Life Sciences discipline and 4-years’ experience in cGMP lab environment, or
Master's Degree in Life Sciences discipline and 2-year experience in cGMP lab environment.
Proficient in Outlook and Microsoft Word and Excel and LIMS/lab-based data management systems.
Experience in GMP Pharmaceutical/Biologics and performing comprehensive data review.
Effective skills in time management, organization, teamwork, collaboration, and leadership
Experience with HPLC, Gel Electrophoresis, UV-Vis Spectroscopy, or wet Chemistry, preferred, not required.
Experience with scientific and technical writing and Empower software desired.
Familiarity with USP and global compendia requirements plus knowledge and experience with discrepancy investigation and lot disposition to meet regulatory requirement desired.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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