Overview
Documentation Associate, Manufacturing (Entry-Level) Jobs in Greater Philadelphia at KVK Tech, Inc.
Title: Documentation Associate, Manufacturing (Entry-Level)
Company: KVK Tech, Inc.
Location: Greater Philadelphia
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
- Professional development reimbursement
- Career growth opportunities
- Tuition reimbursement for children and childcare expense reimbursement
Schedule
- Full-time, on-site position
- Monday–Friday, 8:00 AM – 5:00 PM
