Entry-Level GMP Documentation Specialist

KVK Tech, Inc.; Newtown (PA); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. in Newtown, PA, is seeking a Manufacturing Documentation Associate to provide technical writing and documentation support to Manufacturing and Packaging, maintaining GMP-controlled documents, deviations, change controls, and CAPAs.

Recent graduates with strong writing ability and an interest in pharmaceutical manufacturing are encouraged to apply. Responsibilities include drafting SOPs, tracking revisions, and supporting inspections to ensure compliance and accuracy.

Qualifications

• Bachelor’s degree in English, Technical Writing, Life Sciences, Biology, Chemistry, Pharmaceutical Sciences, Engineering, Manufacturing, Supply Chain, or related field.
• 0–2 years of relevant experience in technical writing, documentation, pharmaceutical manufacturing, packaging, quality, compliance, engineering support, or other regulated industry preferred.

Responsibilities

• Draft, revise, proofread, and maintain SOPs, forms, logbooks, batch record-related documents, protocols, reports, and other GMP-controlled documents.
• Support documentation updates related to manufacturing processes, packaging operations, equipment changes, and compliance improvements.
• Assist with the initiation, review, tracking, and closure of change controls, ensuring documentation is complete, accurate, and appropriately approved.
• Gather information for deviation investigations by reviewing production and equipment records, interviewing relevant personnel, and organizing supporting documentation.
• Assist with documenting root cause assessments, corrective and preventive actions, and follow-up activities under leadership.
• Maintain trackers, spreadsheets, and dashboards to monitor document revisions, investigations, action items, deadlines, and department deliverables.
• Support periodic document reviews, document reconciliation, archival preparation, qualification documentation, and inspection-readiness activities.

Skills

Technical writing

Attention to detail

English writing proficiency

Proactive communication

Education

Bachelor's degree in English/Technical Writing or related field

Tools

Microsoft Word

Excel

PowerPoint

Document management systems

Job description

KVK Tech, Inc. in Newtown, PA, is seeking a Manufacturing Documentation Associate to provide technical writing and documentation support to Manufacturing and Packaging, maintaining GMP-controlled documents, deviations, change controls, and CAPAs.

Recent graduates with strong writing ability and an interest in pharmaceutical manufacturing are encouraged to apply. Responsibilities include drafting SOPs, tracking revisions, and supporting inspections to ensure compliance and accuracy.