Compliance Specialist Senior
Company: Sanofi
Location: Northborough
Posted on: June 25, 2022
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Job Description:
DEPARTMENT DESCRIPTION:QA Disposition is responsible for the
disposition of raw materials and finished products at Sanofi's
Northborough Operations Center, a state-of-the-art multi-product
labeling, packaging, and distribution facility. QA Disposition's
main function is as follows: 1. Ensure cGMPs and market regulations
are adhered to during finished product packaging operations. 2.
Ensure all testing and documentation for raw materials and finished
product meets criteria per applicable Material Specifications ln
support of our main function, our additional areas of
responsibility include; issuing and reviewing/approval of
production records and related support documents, validation study
review/approval, SOP review/approval, finished product inspection,
deviation/CAPA review/approval, external department support
activities and final disposition of finished product and raw
materials for distribution.POSITION OVERVIEW WITH KEY
RESPONSIBILITIES:Core Responsibilities:This position is responsible
for performing a variety of complex tasks working independently
with little to no supervision and in compliance with cGMPs to
support Label and Packaging operations, finished goods, and raw
material disposition.Responsibilities include: Performing finished
product disposition in accordance with Sanofi SOPs, in-house
product specifications and market regulationsReviewing and
approving validation protocols and change controlsAuthoring,
revising and reviewing SOPs through GEODE SystemUtilizing TrackWise
and Phenix to complete investigation of deviations, CAPAs, and
NCMRs and SCARsSupporting compliance walkthroughsParticipate in
internal auditsParticipate in QA audit readiness program as well as
assist and participate in external audits and regulatory
inspectionsInterpreting complex, explicit documentation for new and
current procedures and FDA enforcement actions/trendSCompleting
analysis, identifying issues and providing recommendations for
compliance improvementsCompleting Quality Events in Catsweb and
Comet(SAP)Development and training of new staff as
neededParticipate in specialized projects both within Quality and
cross-functionallyPerform all aspects of Quality Disposition as it
pertains to release activities that will include, but not limited
to the disposition of raw materials and final packaging/component
lotsSupport additional areas of Quality Disposition including
Rejected, Quality Hold and NonConforming Materials Effectively
demonstrates an understanding of GMPs & how it applies to specific
responsibilitiesMaintaining material master data in ERP system
Following accurate oral & written procedures in performing QA
tasksStaying up-to-date on training of all proceduresRoutinely and
safely handle high value product vials in various stages of
packaging completionAdhering to Sanofi's safety procedures and
guidelinesParticipate in Lean initiatives to improve Quality
processesParticipate in the QA consistency meetings to support
continuous improvement effortsSupport the QA on the floor
initiatives which includes; attending daily capacity management and
QDCI meetings and assisting customers with resolution of issues in
real timeEffectively interact on a cross functional basis providing
QA support at the area level and escalate any issues to Management
in a timely fashionEnsure that department goals are achieved and on
time Quality product is realized through execution of primary role
in area of oversight (Batch Record Review, Deviation Management
and/or Lot Disposition, etc.)Comply with the requirements of
Sanofi's health and safety program.Leadership Qualifications:An
ongoing commitment to conducting our global business according to
the highest legal and ethical standards, and to continually pursue
excellence in the development and delivery of all of our products
and services. This includes:Adhering to all applicable laws and
regulations of the places in which we conduct business, as well as
our own Company policies and proceduresBeing honest and treating
people with respect and courtesy.Constantly striving to make Sanofi
a great place to work, and a company respected for the quality of
its people and products.Acting as a role model for our fellow
employees by acting responsibly, fairly, and honestly in our
dealings and exercising sound judgment in performing our
jobs.Leading PeopleSanofi's leaders motivate, inspire, build and
retain highly effective manufacturing teams while managing for high
performance and developing others. They are learners and courageous
decision-makers.Leading the BusinessSanofi's leaders are
effectively operating in an evolving, complex and dynamic
environment, providing clear direction and instruction to direct
reports, and continuously looking internally and externally for
best practices and areas for improvement.Delivering to
CustomersSanofi's leaders understand patient and customer needs and
builds relationships as required to meet manufacturing goals while
continuously improving operations by setting high standards for the
team so they may perform to a level of excellence.BASIC
QUALIFICATIONS:Bachelor's Degree and 4 years of related experience,
High School Diploma and 8 years of related experience in Quality
and /or other CGMP related fields.Knowledge of cGMP regulations for
US, EU, and other marketsExperience with cGMP documentation
reviewExperience training colleaguesAbility to prioritize and
successfully manage multiple competing activitiesPREFERRED
QUALIFICATIONS:Bachelor's degree with 6 years of experience in a
Quality and/or cGMP environment.Industry bio-pharmaceutical
experienceClear communicatorStrong technical writing skillsStrong
computer, verbal, and written communication skillsPerformed
deviation/investigations workflowEffective time management,
detail-oriented, organizational skills, teamwork, and
collaborationTrackwise and/or Phenix system experiencedExperience
with Management Inventory systemExperience with Quality database
systems, e.g. GEODE, and Comet and CatswebSPECIAL WORKING
CONDITIONS:Ability to gown and gain entry to manufacturing
areasMust be able to lift 50 lbs.Requires extended time in
manufacturing areasAs a healthcare company and a vaccine
manufacturer, Sanofi has an important responsibility to protect
individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.Fully vaccinated, according to the CDC, an
individual is considered to be "fully vaccinated" fourteen (14)
days after receiving (a) the second dose of the Moderna or Pfizer
vaccine, or (b) the single dose of the J&J vaccine. Fully
vaccinated, for new Sanofi employees, is to be fully vaccinated 14
DAYS PRIOR TO START DATE. 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-SGLI-GZAt Sanofi diversity and inclusion is foundational to
how we operate and embedded in our Core Values. We recognize to
truly tap into the richness diversity brings we must lead with
inclusion and have a workplace where those differences can thrive
and be leveraged to empower the lives of our colleagues, patients
and customers. We respect and celebrate the diversity of our
people, their backgrounds and experiences and provide equal
opportunity for all.PDN-9661194c-6004-4bd8-a538-b9f119e847f2
Keywords: Sanofi, Worcester , Compliance Specialist Senior, Other , Northborough, Massachusetts
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