Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

Job Title: Professional Technical Writer

Location: Swiftwater, PA

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. 

Responsible for the safety, quality, and delivery of their performance within the Biologics Quality Systems Group. The Technical Writer/Document Coordinator is responsible for authoring document revisions as required per administrative, deviation, CAPA, Change Control and Audit Observations. The role is responsible to ensure these revisions are completed on time to meet site objectives and maintaining a compliant state on the manufacturing floors.

Accountable for the performance of their assignments with respect to all site metrics. They participate in programs to improve employee safety, reduce costs, improve quality, and increase production efficiencies as per established goals. Responsibilities include remaining compliant with cGMP, CBER, and FDA regulations.

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:

Specific responsibilities include:

• Authoring document revisions as required per administrative, deviation, CAPA, Change Control and Audit Observations. Maintaining their items within a state of control and driving to meet site priorities. Maintaining a state of compliance on the manufacturing floor for official documents and logbooks. Maintains records requiring retention per site policies.

• Ensure all Quality Systems operations are conducted in compliance with Health, Safety, Environment regulations. Responsible for engaging, investigating and correcting departures from expectations to ensure the highest safety standards are maintained.

Ensure all Quality Systems operations are conducted in compliance with cGMP’s, safety regulations. Responsible to do the following:

• Ensures documents are written in a compliant manner and serves as reviewer/approver of those items as required.

• Track logbooks and maintain record retention records, as appropriate.

• Participates in the training process for new team members/processes

• Completes CAPA / CCR actions as required

• Responsible for the associated Biologics Quality System function to ensure sufficient bulk product is released at the appropriate time and quality level to meet requirements for domestic, foreign and contracted vaccine sales.

• Participate and support cost reduction initiatives, as assigned.

• Aide in the development of a highly trained organization that is able to respond to a wide variety of demands while respecting the company values and culture. Ensure representation at Level 1 and/or Level 2 +QDCI boards and understand their connection to the Biologics Manufacturing Level 3 boards.

• Strong leadership skills required to lead in a quality focused manufacturing environment. Strong cross-functional working skills to cut across boundaries within and outside Biologics Manufacturing.

• The scope of this role is Biologics Quality Systems within the Swiftwater manufacturing site. This role is responsible for completing quality systems items that impact the timeliness and supply of compliant bacterial or viral vaccine to US and international markets.

Freedom to act, level of autonomy:

• This position should be able to independently support, intermittently and in the short term, at least one of the activities in the Biologics Quality Systems areas (Deviations, CAPA’s, Change Controls and/or Documents).

• Decisions must be made in a dynamic setting taking into account and balancing a changing business environment, business priorities, product and process deadlines and compliance issues.

• Must address internal and external regulatory requirements.

About You

• High School Diploma and 3+ years’ cGMP experience.

• Associate's degree and 2+ years’ cGMP experience

• Bachelor’s degree and 0+ years’ cGMP experience.

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-SP ​
#LI-SP    

#LI-Onsite
#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.