Professional Production Support, Swiftwater, PA


The Professional Production Support role is responsible for ensuring that all document related activities within the Antigen platform are completed compliantly and on time to meet all site objectives and cGMP regulations.?

Key Responsibilities:

Technical Writing

  • Performs and drives completion of documentation updates within the Quality eDoc system.? Edits quality documents (procedures, instructions, specifications, batch records, etc) to ensure compliance with regulatory requirements whether driven administratively or through a Quality system such as Change Control or CAPA

Document Coordination

  • Creates and controls production logbooks (pre, post and during use) and cGMP standalone forms
  • Maintains document control through production floor support, including but not limited to exchanging inactive official copies of documents for active official copies for documents in real time
  • Supports production and continuous improvement needs included change control/CAPA implementation as well as operational optimization
  • Coordinates document revisions and effective dating between multiple groups to ensure a Right First Time environment, open communication and prevention of rework
  • Ensures cGMP regulations (regarding documents, logbooks and forms) are adhered to at all times for the Antigen Platform
  • Record Retention Program:
  • Maintains and coordinates the Record Retention process of GMP documents for the Antigen Platform.? This responsibility includes onsite and offsite record retention.

Basic Qualifications:

  • Bachelor?s Degree
  • Working knowledge of cGMP
  • Proficiency in WORD and EXCEL along with a working knowledge of other MICROSOFT OFFICE programs
  • Experience within Quality eDoc or Documentum related systems as well as Adobe

Preferred Qualifications:

  • Meet/Exceed project timelines/deliverables
  • Experience in document coordination activities
  • Excellent communication?and interpersonal skills (both written and verbal)
  • Excellent attention to detail and organizational skills
  • The ability to work on cross-functional project teams
  • Works quickly with a high degree of accuracy
  • Continuous improvement techniques and problem solving/analytical skills
  • Experience writing deviation investigations
  • Document simplification experience
  • Experience performing agency inspections
  • Strength in several CORE Values ? Respect, Teamwork, Courage and Integrity
  • Strength in several LEAD Competencies - Act for Change, Cooperate Transversally, Develop People ? Self/Others

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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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.

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