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At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Batch Record Reviewer – Vaccine

KEY RESPONSIBILITIES:

• Performs batch record reviews based on business need, and effective procedures. Must be flexible to ensure records are requested for changing business volume and needs.

• Ensure batch records are prepped for production per production schedule

• Prepare additional batch record pages as needed

• Document batch record corrections in electronic correction log

• Work with production to obtain corrections within correction turnaround time

• Provide coaching to Operators on how to properly document production activities

• Identify and communicate to Management any deviations

• Assist in deviation investigation closure

• Enter and verify Shop Floor Data

• Complete PO confirmation and all other SAP phase confirmations

• Utilize visual management tool and Trackwise to track batch records

• Complete corrections for returned records within correction turnaround time

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion.

• Prints new controlled forms and gathers the completed logbooks.

• Utilizes Standards to capture and Record batch record reviews.

• Help manage workload for review and scheduling of record reviews.

• Ensuring daily record review tasks are completed and corrections are addressed.

• Update all metrics and report as needed.

• Perform metric reporting for Filling, Inspection, and Packaging batch records

• Work with Tech Writing Group and Operations for batch record revisions

• Trainer for batch record review

• Perform SAP Troubleshooting

• Support closure of batch record or batch record review process CAPAs/CCs/Deviations actions

• All other duties as assigned by management.

Production Technician - Vaccine

This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.

Their responsibilities are, but are not limited to:

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others.

• Participates in monthly safety meetings.

• Reports all safety issues, concerns, incidents and near misses to the team leadership.

• Actively participates in safety walkthroughs coordinated by the department’s safety team.

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

• Attends Safety Meetings.

Quality:

• FDA audit understanding and awareness. Ensures process in areas is following proper procedures at all times

• Identifies possible deviation occurrences and prevents or aids in investigations and root cause analysis.

• Ensures completion of quality documentation (BFR’s, logbooks, etc) accurately in a timely manner.

• Understands the function of the quality group and works with them to maintain a positive rapport.

• Maintains acceptable execution with no emerging negative trends in procedural deviations

Delivery:

• Performs production in accordance with volume fluctuation, business need, and effective procedures.

• Must be flexible to ensure staffing for changing business volume and needs

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion.

• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation.

• Must ensure maintenance of gowning and Physical dexterity to complete proper set up of machines so not to impact the safety, quality, and integrity of the product.

• All other duties as assigned.

• Adheres to all other company time keeping and attendance policies.

• Ensures all Final Container materials required for production are available prior to need. These materials must be ready for aseptic filling operations to ensure the safety, quality, purity, and integrity of the product is maintained.

• Ensures the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

Cost:

• Executes procedure as documented to avoid deviations.

• Responsibly uses material in an efficient manner to reduce waste.

• Utilizes Filling Standards to capture and Record HRxHR and Change Over Activities.

• Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

Involvement:

• Trains and orients new team members (at any level) as assigned.

• Follows proper documentation as required by cGMP.

• Has a thorough working knowledge of cGMP’s and works to help others understand.

• In on time and attends and participates in Shift Change.

• Maintains acceptable training as described in key requirements. All other duties as assigned.

JOB RESPONSIBILITIES:

• Performs production in accordance with volume fluctuation, business need, and effective procedures.

• Must be flexible to ensure staffing for changing business volume and needs.

• Works with Senior Technicians, leads, and managers to ensure operational area is running as intended to meet all operational goals.

• Must attend shift change daily to ensure preparedness for work day.

• Completes Real Time SAP transactions on all aspects of Inventory Management.

• Obtains and Maintains access to necessary systems as needed (SAP, RT Reports , eDoc, HMI, SCADA access, Virtual Standards, etc.).

• Reports production issues and observations and relays to leadership team.

• Understands science behind process steps and technology including aseptic processing.

• Works to prepare area for oncoming shifts.

• Is trained to complete Environmental Monitoring sampling and corresponding documentation.

• Works with lead technicians and managers to ensure continuous operation.

• Maintains aseptic work environment.

• Must be able to train and work in multiple production areas in the Filling umbrella including material movement, prep, and the aseptic corridor.

• Must ensure training and gowning status is acceptable all time to ensure agility to work in aseptic production areas.

• Must be able to complete training in all areas as required this includes aseptic filling and machine operation.

BASIC QUALIFICATIONS:

• High school diploma or GED with at least 6 months of manufacturing, warehouse or logistics work experience

PREFERRED QUALIFICATIONS:

• Associate or Bachelors' degree in Life Sciences or other relevant fields of study with no prior manufacturing experience necessary.

• Prior work experience in a regulated production environment (e.g., GMP - Good Manufacturing Practice)

• Ability to use Human Machine Interfaces (HMI) to control industrial processes

• Evidence of basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.

The Fine Print

• For influenza production roles (excluding FFIP roles) : candidate must be able to be receive influenza vaccine which is required for building access

• For aseptic area production roles ( excluding Flu production tech roles) : candidate must be able to obtain and maintain current aseptic gowning qualification

• This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.

• Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.

• Able to stand for up to 8 hours a day (with occasional breaks)

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.

Grade: Local

If you want to learn more about compensation grades, please go to our grade guide via the following link:

https://sanofi.sharepoint.com/sites/ST_hr/SitePages/what-is-sanofi-global-grading-and-how-does-it-work-.aspx

Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.

Our people are responsible for managing their career

Sanofi posts all non-executive opportunities for our people

We give priority to internal candidates

Managers provide constructive feedback to all internal interviewed candidates

We embrace diversity to hire best talent

We expect managers to encourage career moves across the whole organization

A few practical tips:

Be sure to regularly update your Workday profile to simplify the application process

Be aware of any applicable eligibility criteria in the country to which you are applying

Before applying, inform your manager so they may support your career development goals

Sanofi careers - it all starts with you!

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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) !