Documentation Associate, Manufacturing (Entry-Level)

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

The Manufacturing Documentation Associate supports Manufacturing and Packaging by preparing, revising, proofreading, and maintaining GMP documentation, including SOPs, forms, logbooks, trackers, reports, and related controlled documents. This is a documentation-focused role that requires strong writing ability, attention to detail, organization, and the ability to communicate with cross-functional teams in a regulated pharmaceutical manufacturing environment.

The primary focus is technical writing, SOP/documentation support, documentation tracking, and maintaining accurate, inspection-ready records in accordance with cGMP and data integrity expectations.

Key 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.

What We’re Looking For

Experience:

• 0–2 years of relevant experience in technical writing, documentation, pharmaceutical manufacturing, packaging, quality, compliance, engineering support, or another regulated industry preferred.
• Prior experience drafting, revising, proofreading, or maintaining SOPs, work instructions, forms, reports, controlled documents, or technical documentation preferred.
• Prior experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, food, chemical, or other regulated manufacturing environment preferred but not required.
• Recent graduates with strong writing ability, internship experience, co-op experience, academic writing experience, or demonstrated documentation skills are encouraged to apply.
• Familiarity with SOPs, change controls, deviations, CAPAs, investigations, qualification documentation, or document management systems preferred.

Education:

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

Skills & Knowledge:

• Excellent English writing, spelling, grammar, punctuation, proofreading, and editing skills.
• Strong ability to write clearly, accurately, and objectively in a regulated documentation environment.
• Strong attention to detail and ability to identify inconsistencies, missing information, formatting errors, and documentation gaps.
• Ability to review records, organize information, summarize facts, and support documentation related to SOPs, change controls, deviations, CAPAs, and process improvements.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Ability to create, update, and maintain spreadsheets, trackers, tables, and basic dashboards.
• Strong organizational skills with the ability to manage multiple documents, deadlines, trackers, and follow-up items simultaneously.
• Ability to communicate professionally with cross-functional teams and maintain confidentiality when handling sensitive information.
• Working knowledge of cGMP requirements, Good Documentation Practices, ALCOA principles, and data integrity expectations preferred.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Tuition reimbursement for children and childcare expense reimbursement