GMP Documentation & Quality Systems Specialist

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan with company match

Stock-based long-term incentives

Discretionary annual bonus program

Flexible work models where possible

Job summary

Amgen seeks a qualified professional to support the manufacturing team by drafting and revising SOPs, WI, and technical reports in a GMP environment. This role leads quality records such as deviations, CAPAs, and change controls with SME input.

You will collaborate across departments to improve documentation, training materials, and process improvements while ensuring timely, accurate records.

Qualifications

• Doctorate degree required in a relevant field.
• Masters degree with 2 years in Engineering, Manufacturing, Packaging or Quality in pharmaceutical/biotech sectors.
• Bachelor's degree with 4 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.
• Associate's degree with 8 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.
• High school diploma / GED with 10 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.

Responsibilities

• Develop, review, and update technical content including SOPs, WIs, risk assessments, protocols and reports for manufacturing.
• Generate, own, and provide SME to Quality System records such as deviations, CAPA and change control records.
• Provide technical and clerical support to the manufacturing team in documenting, data collation and tracking.
• Liaise with manufacturing and cross-functional departments on documentation changes.
• Collaborate with multiple departments to support training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and troubleshooting projects.
• Assist in reducing document turnaround times for the manufacturing team.
• Ensure actions are completed on schedule and documents are current.
• Develop protocols for execution in Manufacturing to support change controls and investigations.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to maintain GMP standards.
• Share knowledge with manufacturing team members.

Education

Doctorate degree

Master's degree with 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Bachelor's degree with 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Associate's degree with 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

High school diploma / GED with 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Job description

Amgen seeks a qualified professional to support the manufacturing team by drafting and revising SOPs, WI, and technical reports in a GMP environment. This role leads quality records such as deviations, CAPAs, and change controls with SME input.

You will collaborate across departments to improve documentation, training materials, and process improvements while ensuring timely, accurate records.