Documentation Associate, Manufacturing

About the Role

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 requiring 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.

Requirements & Tech Stack

• 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.

Qualifications

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

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