GMP Documentation Specialist
Meet Life Sciences, San Antonio, TX, United States
Job Title:
GMP Documentation Specialist – Biologics Manufacturing
Overview We are seeking a detail-oriented GMP Documentation Specialist with hands‑on experience in biologics manufacturing to support cGMP operations. This is a project‑based role focused on creating, reviewing, and managing GMP documentation in a regulated environment.
Key Responsibilities
Author, review, and maintain GMP documentation including SOPs, batch records, work instructions, and forms
Ensure documentation aligns with cGMP standards and regulatory requirements (FDA, EMA, ICH)
Support document control processes including versioning, change control, and archival
Collaborate with Manufacturing, Quality Assurance, and other cross‑functional teams to ensure accuracy and compliance
Assist with deviations, CAPAs, and change controls related to documentation updates
Support internal and external audits by providing documentation and ensuring inspection readiness
Qualifications
Bachelor’s degree in Life Sciences or related field (or equivalent experience)
3+ years of experience in GMP documentation within biologics, pharma, or CDMO environments
Strong understanding of cGMP regulations and documentation practices
Experience with document management systems (e.g., Veeva, MasterControl) preferred
Excellent attention to detail, organization, and communication skills
Preferred Experience
Prior experience in biologics or cell/gene therapy manufacturing
Exposure to regulatory inspections and audit support
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GMP Documentation Specialist – Biologics Manufacturing
Overview We are seeking a detail-oriented GMP Documentation Specialist with hands‑on experience in biologics manufacturing to support cGMP operations. This is a project‑based role focused on creating, reviewing, and managing GMP documentation in a regulated environment.
Key Responsibilities
Author, review, and maintain GMP documentation including SOPs, batch records, work instructions, and forms
Ensure documentation aligns with cGMP standards and regulatory requirements (FDA, EMA, ICH)
Support document control processes including versioning, change control, and archival
Collaborate with Manufacturing, Quality Assurance, and other cross‑functional teams to ensure accuracy and compliance
Assist with deviations, CAPAs, and change controls related to documentation updates
Support internal and external audits by providing documentation and ensuring inspection readiness
Qualifications
Bachelor’s degree in Life Sciences or related field (or equivalent experience)
3+ years of experience in GMP documentation within biologics, pharma, or CDMO environments
Strong understanding of cGMP regulations and documentation practices
Experience with document management systems (e.g., Veeva, MasterControl) preferred
Excellent attention to detail, organization, and communication skills
Preferred Experience
Prior experience in biologics or cell/gene therapy manufacturing
Exposure to regulatory inspections and audit support
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