Quality Control Analyst

BioSpace; Framingham (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Parental leave

Career growth opportunities

Job summary

Sanofi is seeking a Quality Control Analyst in Framingham, MA to perform routine and complex testing of in-process and final product samples per SOPs and CGMP guidelines. You will help with method development, qualification, validation, and investigations while maintaining meticulous records and ensuring data integrity.

The role requires 2+ years lab experience (Bachelor's) or 0-1 year with a Master's, with strong attention to detail and teamwork.

Qualifications

• Bachelor's degree or equivalent and 2+ years laboratory experience.
• Master's degree or equivalent and 0-1 year experience.
• Basic knowledge in the required method platform (e.g. Bioburden, TOC, Endotoxin, Water Chemistry, ELISA).
• Attention to detail, and able to maintain accurate records with excellent proofreading skills
• Able to communicate effectively with others
• Able to work effectively both independently and as a member of a team
• Proficient with Microsoft Office tools such as: Word, Excel & Powerpoint.

Responsibilities

• Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.
• Perform maintenance on complex laboratory equipment.
• Review data for compliance to procedures and specifications.
• Calculate and evaluate results.
• Make detailed observations in support of Alert, Action and OOS result investigations.
• Participate in writing and revising SOPs.
• Assists in the qualification of new controls, standards and reagents
• Effectively demonstrate an understanding of and work in compliance with CGMPs.
• Practice safe work habits and adhere to CGMPs safety procedures and guidelines.
• Actively participate in problem solving meetings with senior staff members and suggest process improvements.
• Independently work under supervision and direction.

Skills

Attention to detail

Effective communication

Independent worker

Team collaboration

Education

Bachelor's degree or equivalent

Master's degree or equivalent

Tools

Microsoft Office

Job description

About The Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

Job Details

Job title: Quality Control Analyst

Location: Framingham, MA

Shift: Sun-Wed 10am-8:30pm

Department Description

Quality Control Microbiology (QCM) 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.

Position Summary

This position is responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs and relevant procedures for method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

• Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.
• Perform maintenance on complex laboratory equipment.
• Review data for compliance to procedures and specifications.
• Calculate and evaluate results.
• Make detailed observations in support of Alert, Action and OOS result investigations.
• Participate in writing and revising SOPs.
• Assists in the qualification of new controls, standards and reagents
• Effectively demonstrate an understanding of and work in compliance with CGMPs.
• Practice safe work habits and adhere to Genzymes safety procedures and guidelines.
• Actively participate in problem solving meetings with senior staff members and suggest process improvements.
• Independently work under supervision and direction.

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

About You

Leadership Qualifications:

An Ongoing Commitment To Conducting Our Global Business According To The Highest Legal And Ethical Standards, And To Continually Pursue Excellence In The Development And Delivery Of All Of Our Products And Services. This Includes

Being a Subject Matter Expert (SME)/Trainer/Coach to other analysts within the laboratory.

Constantly striving to make Genzyme 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.

Basic Qualifications

• Bachelors degree or equivalent and 2 + years laboratory experience.
• Masters degree or equivalent and 0-1 year experience.
• Basic knowledge (i.e. 1-2 years experience) in the required method platform (e.g. Bioburden, TOC, Endotoxin, Water Chemistry, ELISA).
• Attention to detail, and able to maintain accurate records with excellent proofreading skills
• Able to communicate effectively with others
• Able to work effectively both independently and as a member of a team
• Proficient with Microsoft Office tools such as: Word, Excel & Powerpoint.

Preferred Qualifications

• Experience in GMP lab environment.
• Experience with lab based data management systems.
• Experience in a quality control lab.

Special Working Conditions

Work in a laboratory with minimal use of chemicals.

Ability to lift 10 lbs.

All or part of the information contained in this document should be treated as the property of Sanofi or its affiliates. It cannot be published or divulged for whatever purpose to any third party, unless an appropriate non-disclosure agreement has been signed by the third party and prior approval is obtained from the Sanofi function owning this document.

Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an at will employment relationship.

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 its 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

#GD-SG

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.