GMP Documentation Specialist – Supply Chain

Planet Pharma

Branchburg Township (NJ)

On-site

USD 40,000 - 57,000

Full time

3 days ago
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Job summary

Planet Pharma in Branchburg, NJ is seeking a documentation-focused professional to develop and update processing documentation for manufacturing operations.

You will author SOPs, work instructions, specifications, and drive change through GMP controls, CAPA closures, and cross-functional collaboration to ensure compliance and process improvement.

This role emphasizes strong writing skills, attention to detail, and ability to coordinate with Quality and Supply Chain teams.

Qualifications

  • Bachelor’s degree in scientific discipline or 5+ years of equivalent experience.
  • 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.

Responsibilities

  • 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.

Skills

Strong communication skills
Technical writing
Process improvement
Cross-functional collaboration

Education

Bachelor’s degree in scientific discipline

Tools

MS Office Suite (Word, Excel, Access, PowerPoint)

Job description

Planet Pharma in Branchburg, NJ is seeking a documentation-focused professional to develop and update processing documentation for manufacturing operations.

You will author SOPs, work instructions, specifications, and drive change through GMP controls, CAPA closures, and cross-functional collaboration to ensure compliance and process improvement.

This role emphasizes strong writing skills, attention to detail, and ability to coordinate with Quality and Supply Chain teams.

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