GMP Documentation Specialist – Manufacturing

KVK Tech, Inc.; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus eligibility

401(k) with company match

Paid Time Off

10 paid company holidays

Comprehensive medical, dental, vision,

Life insurance

Tuition reimbursement

Childcare expense reimbursement

Job summary

KVK Tech, Inc. is seeking a Manufacturing Documentation Associate to support Manufacturing and Packaging by preparing, revising, proofreading, and maintaining GMP documentation including SOPs, forms, and logbooks.

The role emphasizes strong writing, detail, and organized record-keeping in a regulated pharmaceutical environment. The primary focus is on technical writing, SOP documentation support, documentation tracking, and ensuring inspection-ready records in line with cGMP and ALCOA

Qualifications

• Bachelor’s degree in a relevant field and strong writing ability.
• Experience drafting, revising, proofreading or maintaining SOPs and other controlled documents is preferred.
• Familiarity with cGMP and data integrity expectations is a plus.

Responsibilities

• Draft, revise, format, proofread, and maintain SOPs, forms, logbooks, reports, trackers, and other GMP-controlled documents.
• Support Manufacturing and Packaging teams with documentation updates related to processes, equipment, compliance improvements, and operational changes.
• Assist with documentation activities related to change controls, deviations, CAPAs, investigations, and process improvement initiatives.
• Review production records, equipment logs, maintenance records, and other supporting documentation to gather accurate information and identify documentation needs.
• Maintain spreadsheets, trackers, databases, and dashboards used to monitor SOP revisions, action items, change controls, deviations, CAPAs, and project deliverables.
• Communicate with Manufacturing, Packaging, Engineering, Quality Assurance, Validation, and Regulatory Affairs personnel to gather information, confirm details, and track documentation progress.
• Maintain accurate, organized, and inspection-ready documentation in accordance with cGMP requirements, Good Documentation Practices, ALCOA principles, and internal documentation standards.

Skills

Technical writing

Attention to detail

Cross-functional communication

Organizational skills

Regulatory documentation

Education

Bachelor’s degree in English, Technical Writing, Life Sciences, Biology, Chemistry, Pharmaceutical Sciences, Engineering, Manufacturing, Supply Chain, or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft PowerPoint

Job description

KVK Tech, Inc. is seeking a Manufacturing Documentation Associate to support Manufacturing and Packaging by preparing, revising, proofreading, and maintaining GMP documentation including SOPs, forms, and logbooks.

The role emphasizes strong writing, detail, and organized record-keeping in a regulated pharmaceutical environment. The primary focus is on technical writing, SOP documentation support, documentation tracking, and ensuring inspection-ready records in line with cGMP and ALCOA