Compliance Specialist
Sanofi Group
**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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**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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
_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:
$67,500.00 - $97,500.00
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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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