Job Details

Target PR Range: 35-475/hr DOE

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

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.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about accountability and scope.

• 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.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• 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