Manufacturing Documentation Associate

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 is seeking a Manufacturing Documentation Associate to join our team in Newtown, PA.

The Manufacturing Documentation Associate will provide technical writing and documentation support to Manufacturing, Packaging departments primarily. This role supports the preparation and maintenance of GMP-controlled documents, deviation investigations, change controls, and corrective and preventive actions to ensure accurate records and operational compliance.

Recent graduates with strong writing ability and an interest in pharmaceutical manufacturing are encouraged to apply.

This position’s responsibilities will include, but not be limited to the following:

• 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 the direction of Manufacturing, Quality, or Engineering 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.

We Are Looking For Applicants With

• Bachelor’s degree in English, Technical Writing, Life Sciences, Biology, Chemistry, Pharmaceutical Sciences, Engineering, Manufacturing, Supply Chain, or a related field required; equivalent combinations of education and relevant experience may be considered.
• 0–2 years of relevant experience in technical writing, documentation, pharmaceutical manufacturing, packaging, quality, compliance, engineering support, or another regulated industry preferred. Relevant internship and co-op experience will be considered.
• Excellent English writing, grammar, spelling, punctuation, and proofreading skills, with the ability to communicate technical information clearly.
• Strong attention to detail and the ability to review records, organize factual information, and maintain accurate documentation.
• Proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint; experience with document management systems, databases, or tracking tools preferred.
• Familiarity with cGMP requirements, controlled documents, deviations, change controls, CAPAs, and ALCOA data integrity principles preferred.

What We Offer

• 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

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.