- Pay: $39-44.88/hr depending on experience
- Location: Onsite in Sommerville, NJ
- Develop and update processing documentation for manufacturing operations and facilitate CAPA closures within Supply Chain
- Author SOPs, work instructions, specifications, and work instructions, and provide associated documentation through the various change management processes
- Actively participate in the authoring of Operations related process improvement initiatives
- Partner with SMEs in the Supply Chain team in creating or revising various GMP documents, including (but not limited to) SOPs, forms, work instructions, specifications, Change Controls, etc.
- Develop standards for type of content and formatting of SOPs and other documents
- Ensure logical organization of documents, while minimizing gaps and duplication
- Partner with counterparts of Supply Chain to ensure consistency of type of content and formatting for GMP documents
- Coordinate with the Quality group to ensure all GMP documents for Operations meet or exceed compliance expectations
- Compile supporting documentation and ensure all change management requirements for GMP documentation are met
- Follow up with reviewers and approvers for timely completion
- Work closely with Supply Chain personnel for scheduling and completing documentation process related activities
- Bachelor's degree in scientific discipline or 5+ years of equivalent experience required
- Strong communication skills, both oral and written
- 3-6 years relevant experience in a pharmaceutical manufacturing-related field
- Previous technical writing and/or training experience preferred
- Exceptionally strong written and verbal communication skills
- Ability to communicate with all levels of the organization
- Demonstrated creative thinking skills
- Must be proficient with Microsoft Office applications, including Word, Excel, Access and Power Point
- Experience with more advanced document management applications a plus
- Experience with process improvement systems and techniques
- Other functions of the role include (but are not limited to) change planning, meeting facilitation and management, change proposal review, developing communications and leveraging employee feedback and data for improvement
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