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- Team player
Culture: Play to Win
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."Shannon Resetich US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."Mouhamed Gueye US Head Medical Rare Blood Disorders
JOB TITLE:DEPARTMENT:QA Document Control Pre-Production Analyst Quality Assurance
REPORTS TO: QA Project Manager
Batch Record control issue
Master Packaging Records for production
Support continuous improvement of document structure, and coordinates documents requirements from various departments such as Packaging, Audit Group, Change Control and Planner in relation to the Batch Record
SCOPE of RESPONSIBILITIES:
Manage the implementation of Master Processing Records.
Manage the creation and revision, accuracy and completeness of the Batch Packaging Record through a pre-production quality review.
Interact with related departments involved in the generation of a Master Batch Record, i.e. planning, packaging, change control product development, and audit group.
Assess documents against current GDP and GMP procedures. Provides support for computer validation and Q.A. metrics.
ESSENTIAL JOB FUNCTIONS:
Point of contact for executing creation or revision of Batch Records.
Manage the pre-production quality review of Batch Records.
Point of Quality approval for Master Batch Packaging Records
Maintain Metrics for Document Control.
Participate in Computer Validation efforts for the site.
Continuous improvement of Batch Packaging Record for approximately 460 documents. The steps required but not limited to are the following to execute the task:
Receive New Product SPI information from Planning
Receive New Set-Up information from Packaging
Receive New Audit Sheet Information From Audit Group
Based on Set-Up Sheet choose line From Templates
Record must be updated through Change Control
Record for on-line viewing in PDF format
Check Sheet finalization, obtain signatures
Other duties as needed
Expert in Microsoft Word, Excel
Proficient in Adobe pdf, and outlook, power BI helpful but not required.
Strong interpersonal skills
Ability to multitasking, flexible to schedule changes, ability to prioritize, and self-driven in their role.
Proficient knowledge of FDA regulations.
Need to be able to follow and enforce policies and procedures
To be knowledgeable in current Good Manufacturing Practices and Good Documentation Practices.
PERSONNEL REPORTING to
QA DOCUMENT CONTROL SPECIALIST:
Direct Reporting Responsibilities: None
Indirect Reporting Responsibilities: None
EDUCATION or EXPERIENCE:
Some college preferred 3-5 years related experience
Prefer 2-3 years experience in composing documents
Ability to utilize Microsoft Word, Excel, Outlook, and Power BI preferred
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. Although not required at this time, all Tennessee based roles are encouraged to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
At 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.