GMP Document Control & QA Records Specialist

The Goodkind Co; Round Rock (TX); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

11 Paid Holidays

PTO

401K

Job summary

Goodkind is seeking a detail-oriented Document Control Specialist to manage revision control for SOPs, WIs, and Forms within the QMS. You will ensure current, approved revisions are available and coordinate with Change Control for timely releases.

The role requires GMP knowledge, experience with eQMS/EDMS, and strong attention to detail. This position reports to the Quality Assurance Supervisor and supports QA batch kit reviews and audits, maintaining accurate logs and ensuring regulatory

Qualifications

• Bachelor’s degree in Life Sciences, Technical Writing, Business, or related field (or equivalent experience)
• 3+ years of experience in document control within a regulated industry (pharma, biotech, medical device, cosmetics or food manufacturing)
• Knowledge of GMP and documentation standards
• Experience with document management systems (eQMS/EDMS)
• Proficiency in Google Suite (Google Docs, Sheets, Slides)

Responsibilities

• Manage document revision control: versioning, numbering, issuance, lifecycle management of controlled documents
• Ensure current, approved revisions of SOPs, WIs, and Forms are available for use
• Coordinate review, approval, and release of revised documents through change control processes
• Maintain revision history logs and audit trails in Google Suite/eQMS
• Support change control activities to align with approved changes
• Archive obsolete documents and enforce retention and retrieval procedures
• Support validation documentation updates impacted by process or system changes
• Assist with audits by retrieving controlled documents and batch records
• Generate and track metrics related to document revisions and batch kit review status
• Perform additional duties as assigned

Skills

GMP knowledge

Document control

Cross-functional collaboration

Strong communication

Education

Bachelor's degree in Life Sciences/related field

Tools

Google Suite

Job description

Goodkind is seeking a detail-oriented Document Control Specialist to manage revision control for SOPs, WIs, and Forms within the QMS. You will ensure current, approved revisions are available and coordinate with Change Control for timely releases.

The role requires GMP knowledge, experience with eQMS/EDMS, and strong attention to detail. This position reports to the Quality Assurance Supervisor and supports QA batch kit reviews and audits, maintaining accurate logs and ensuring regulatory