Quality Control Analyst II

Posted 4 Days Ago
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Framingham, MA
Entry level
Healthtech
The Role
The Quality Control Analyst II role involves performing analytical testing on medical and pharmaceutical products, ensuring adherence to SOPs and GMP in a lab environment. Responsibilities include conducting stability and release testing, reviewing peer data, initiating investigations, and participating in audits. Additionally, the analyst will maintain lab equipment and assist with method validations while working towards site quality and safety goals.
Summary Generated by Built In

Job title: Quality Control Analyst II

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.

The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the 74/76 NYA Manufacturing Facility. The department performs analytical testing on intermediate, in-process and final product materials using a variety of equipment to include GC, FTIR, UV VIS, and physical property instrumentation.

**1st shift- Monday-Friday- flexible start/end time

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:

  • Supports Biosurgery Business by performing in-process, stability and release testing for

  • Biosurgery Product lines.

  • Core Responsibilities

  • Perform Assays in accordance with SOPs for release, stability and in-process samples.

  • Review peer data including data transcription, data calculation and log entries.

  • Lab general duties including cleaning, glassware, washing, etc.

  • Initiate DCR when assigned.

  • Train on all documents assigned to training plan and complete training as assigned.

  • Receive, verify and log incoming samples.

  • Perform or participate in Equipment Qualifications.

  • Perform or participate in Method Validations.

  • Participate in audits.

  • Complete training as assigned.

  • Author technical reports.

  • Bring in new equipment (spec, URS, etc.)

  • Perform PM or calibration on lab equipment.

  • Conduct safety and weekly compliance walkthroughs.

  • Responsible for adherence to policies, procedures and SOPs.

  • Participate in Lab Investigations.

  • Perform OOS investigations as Analyst.

  • Adhere to Site Quality and Safety Policies.

  • Work toward accomplishment of Site Goals.

  • Initiate and help investigate deviations through Phenix.

  • QC testing of in-process, stability and release samples in a GMP lab.

  • Troubleshooting of assay/equipment issues.

  • Coordinator Roles that may be assigned:

  • Metrology

  • Purchasing

  • Documentation

  • CSO

  • Safety

  • Assay occasion tracking

  • Logs

  • Reserves

  • Product Point of Contact

  • Data Back Up

About You

Basic Qualifications:

  • One of the following:

  • High School Diploma with minimum of 4 Years of relevant industry experience.

  • Associates Degree with 2-4 Years of relevant industry experience.

  • Bachelor’s Degree with 0-2 Years of relevant industry experience.

  • Proficient with Microsoft Office tools such as: Word, Excel & PowerPoint

Preferred Qualifications

  • 1 Year Experience in GMP lab environment.

  • Experience in laboratory techniques such as: pH, GC, UV/VIS and FTIR.

  • Proficiency in Microsoft Office tools such as: Word, Excel & PowerPoint.

  • Strong attention to detail and ability to multitask.

Special Working Conditions

  • Requires working with hazardous chemicals.

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.

#GD-SG   
#LI-GZ 
#LI-Onsite
#vhd

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Top Skills

Ftir
Gc
Gmp
Uv Vis
The Company
HQ: Paris
85,000 Employees
On-site Workplace
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

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