Job Description

Job Description

Job Title: Compliance Specialist

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. 

The Compliance Specialist will be responsible for managing all compliance related items for the Computerized Maintenance Management System (CMMS), such as gatekeeper, designation of notifications to appropriate personnel, processing of notifications for requests of extensions, master data updates/corrections, preventive maintenance changes and work order processes. This includes but is not limited to the creation and updating of equipment records, maintenance items, maintenance plans and task lists. In addition, the Compliance Specialist will provide aid and support for the Computerized Maintenance Management System.

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

• Manage compliance related items in CCMS (notifications for Master Data additions and updates including Peventive Maintenance (PM) changes, extensions, Bill of Materials (BOM) updates, relocations/disposal of equipment)

• Ensure timely completion of tasks (extensions, work orders, updates/corrections)

• Help coordinate inspection / audit preparation and responses concerning the CMMS System.

• Drive reductions of rework for extensions and master data changes

• Monitor changes in processes and implement improvements to the CMMS System.

• Manages work order attachment process in CMMS

• Manages archiving of work order attachments through QualiPSO and contracted archival company

• Create and provide equipment number/functional location tags

Related KPIs & Metrics

• On-time completion of compliance related items including extensions

• On-time inspection / audit response concering CMMS

• Rate of return of requests with root causes for rework

• Rate of reaccurance of late PMs.

• Other metrics for the Compliance Group (extensions, work order #s, PM changes)

About You

Education & Experience & Certifications

• HS diploma or equivalent and 3+ years in cGMP or Pharmaceutical experience

• Associates degree with 2 + years in cGMP or Pharmaceutical experience

• Bachelors degree with 1 + years in cGMP or Pharmaceutical experience

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary and multiorganizational teams.

• Strong problem-solving abilities, with a focus on identifying and resolving issues quickly and efficiently

• Proficiency with Microsoft Office suite

• Proficiency in SAP; SAP S4/HANA experience a plus.

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. 

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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.

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