Offers “Sanofi”

Expires soon Sanofi

Quality Systems Production Support

  • Internship
  • Swiftwater, USA

Job description



Quality Systems Production Support

The Quality Systems Production Support incumbent performs and supports the change control, CAPA, internal audit and document processes for the Antigen Platform.

Roles and Responsibilities:  

·  CAPA, CC, Document and Internal Audit point of contact for an assigned area in the Antigen Platform
·  Contributes to a team composed of a combination of Technicians, Technical Writers, Operations Managers, and Production Support, that is responsible for timely closure of Quality Items and supporting Antigen in keeping in a compliant and audit ready state.
·  Facilitates cross-functional interfacing activities with stakeholders in a very positive manner: Quality Control, Manufacturing Technology, Maintenance, Metrology, Sterility Assurance, and Quality Assurance.
·  Responsible for facilitating Change Control, CAPA, Document and Internal Audit Processes to assist in the implementation of the appropriate corrective and preventive actions resulting from deviations as well as process improvements from the Antigen Continuous Improvement group.
·  Writes, leads, and manages actions and timelines associated with Change Controls and CAPAs
·  Serves as the Antigen Quality Systems point of contact for assigned area during internal audits and Building startups
·  Aids in prioritizing technical writer priorities to complete all quality system related action items in a timely manner
·  Facilitates resolution of issues and deliverables by leading meetings, positively influencing functional managers, removing obstacles and managing projects and priorities, which are critical to ensuring timelines are met
·  Assures that operations are in compliance with Quality Systems, cGMP, CBER, WHO, EP and other regulatory bodies.
·  Required to possess and demonstrate excellent interpersonal/communication skills and management by influence skills, flexibility and the ability to lead and participate on teams. 

Basic Qualifications:

·  Bachelor’s level degree or higher
·  Proficient in Microsoft Office (Excel, Word and PowerPoint)
·  Excellent communication skills

Preferred Qualifications:

·  Bachelor’s level degree in Life Sciences with experience working within a production department of a pharmaceutical or Biotech Company.
·  Working knowledge of cGMP's.
·  Understanding of cGMPs and manufacturing activities
·  Experience working in a QA or manufacturing environment
·  Ability to work well under pressure and communicate effectively to multiple levels within an organization
·  Excellent technical writing skills as applied to the generation of Change Controls, CAPAs, Audit Responses and Document Creation
·  Good project management and organizational skills.
·  Strong time management and prioritization skills
·  Knowledgeable in ERP system (SAP preferred)
·  Quality Management Systems (TrackWise NA, Trackwise Global, Phenix)
·  Previous Technical Writing experience (Including Deviations)

NOTE:  Candidate must be able to work overtime and flexible hours, including

weekends.



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-SP   

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.

Make every future a success.
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