QC Analyst

Job Title: QC Analyst

Location: Framingham, MA

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.

Quality Control is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for cGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting in site wide studies and projects.

The Quality Control Data Reviewer is responsible for providing expert quality review of complex QC testing documents in accordance with SOPs, relevant procedures for method development, qualifications, validation, method transfers, product release, stability, process validations, and investigation, in compliance with cGMP. The Quality Control Data Reviewer is also committed to the conducting global business according to the highest legal and ethical standards, and to continually pursue excellence in the development of all of our products and services. This includes:

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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 and specifications, and current cGMPs.

• Perform expert and comprehensive data review to support routine QC and Manufacturing operations, investigations, and product lot release.

• Experience in testing and reviewing compendial QC Assays i.e., HPLC, UPLC, ELISA, gels, A280, Biocore, etc. .

• Demonstrate proficiency in understanding and applying Good Documentation Practices, cGMPs, and Good Laboratory Practices in a Quality Control Laboratory.

• Data entry and filing of documentation, maintenance of laboratory testing files, and archiving of test records and logbooks

• Demonstrate proficiency and adaptability of working with different Quality Control LIMS software systems.

• Create weekly metrics to assess, evaluate, and ensure occurrence of timely data review for all assays.

• Escalate issues identified during review, driving investigations and cross functional meetings (i.e. Gembas)

• Maintain and Perform Logbook Reviews

• Interact with different departments to support timely and accurate data review for all assays.

• Collaborate on Quality Control method investigation and corrective action implementation

• Work effectively with others to achieve shared goals.

• Revise procedure/ drive the SOP revision process

• Provide on the floor (OTF) support to the operations department

• May provide training to new employees

• Excellent communication skills, self-independent, and motivated

• Support internal and external audit activities and conduct walkthrough inspections

Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

About You

Basic Qualifications:

• 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

• Experience with performing comprehensive data review

• Effective skills in time management, organization, teamwork, collaboration, and leadership

Preferred Qualifications:

• Knowledge/Experience with scientific and technical writing

• Experience with compendial QC methods and global compendia requirements

• Know