Job title: Material Release Quality Technician

Location: Swiftwater, PA

About the Job

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

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. 

This position will perform Quality inspections on incoming material inspections, documentation verification, statistical sample removal, and status tagging of materials by strictly adhering to Sanofi policies and procedures and cGMP.  They will also be required to perform cleaning of work areas, equipment, and any other jobs as required, ensure all duties are completed on time, and complete required Safety and Compliance training and associated training modules as assigned.

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?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives. 

Main Responsibilities:

• Performs inspection, sampling, testing, and release of raw materials by strictly adhering to SOPs, SWIs, material specifications, Federal Regulations, cGMP, training modules, Sanofi policies and procedures, and safety guidelines.  These activities are performed as dictated by IQ MR management to meet the demands of the production schedule.

• Maintains laboratory in a safe and compliant state.  Manages inventory of raw material sampling utensils, sample containers, and safety supplies.  Performs cleaning of laboratories sampling equipment as required.

• Processes and inspects product samples from contract manufacturers as well as other Sanofi sites.  Ensures cold chain of custody is kept on samples and samples are distributed to the applicable testing unit.  Ensures cold chain of custody is maintained.

• Performs inspections for raw materials within the building 38 warehouse and associated off site warehouse locations.  Performs inspections and sampling for intermediates, final bulks, final containers, and finished product released by Product Release.

• Attends and contributes to scheduled team meetings, department meetings, and safety meetings.  Performs document and procedure review as needed.  Trains on departmental training modules as assigned.  Pursues professional and or technical development training on/off site.

• Understand and support implementation of change controls, CAPAs, and deviation corrective actions.  Notifies lab manager of any deviations or issues and initiates deviation investigations as required.  Supports deviation investigations.

• Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly.  Non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall, and a significant risk to the site’s continued operation.

• Attention to detail in recording GMP data right first time into GXP documents. 

• The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones.

• The ability to negotiate, work with and influence a variety of people in a positive manner while identifying, and working to solve problems is a requirement of the position.  

• The incumbent must be able to work effectively with colleagues at other Sanofi, contract sites, and outside vendors to ensure that GMP data is available in a timely manner.

• The position may require that the incumbent interacts with external customers as a representative of Quality Operations.  External companies include raw material vendors and other Sanofi sites on a global level. 

• The incumbent must process raw material batches to ensure timely disposition within agreed upon timelines to support production scheduling and or marketing expectations.

• The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.

About You

Basic Qualifications:

• High school diploma or equivalent, with a minimum of 1 year of relevant experience in a cGMP-regulated pharmaceutical or biotechnology environment.

• Strong organizational, written, interpersonal, and teamwork skills.

• Solid understanding of current Good Manufacturing Practices (cGMPs)

Preferred Qualifications:

• Bachelor’s degree (BA/BS) in Life Sciences or a related field, with at least 1 year of relevant experience in a cGMP-controlled pharmaceutical setting.

• Experience with systems such as SAP, LabWare, EDMS, FaCT, SMS, and Aseptic Technique is a plus.

• Forklift Certification preferred.

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 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. 

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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.

North America Applicants Only

The salary range for this position is:

$24.00 - $32.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.