Documentation Associate

Responsibilities

• Prepare, revise, and maintain analytical methods, test procedures, and specifications within controlled documentation systems.
• Track compendial updates (USP/NF, EP, JP) and update impacted methods and specifications in accordance with regulatory timelines.
• Process documentation change control requests, ensuring proper review, routing, and timely closure.
• Validate, maintain, and monitor controlled Excel spreadsheets and Empower calculations to ensure compliance with ALCOA+ data integrity expectations.
• Organize, file, label, and archive QC documentation (paper and electronic) in alignment with retention and SOP requirements.
• Research technical or compendial information to support updates and provide documentation guidance to QC personnel.
• Collaborate with QC analysts, supervisors, and QA reviewers to resolve documentation discrepancies and ensure consistent documentation practices.

Requirements

• Aceessory’s degree in a scientific discipline or related field required; Bachelor’s degree preferred.
• 1–2 years of experience in a GMP-regulated pharmaceutical environment, preferably within documentation control or QC.
• Working knowledge of cGMP, GLP, FDA expectations, and data integrity principles (ALCOA+).
• Strong proficiency in Microsoft Word and Excel, with familiarity in controlled spreadsheets and formula validation.
• Excellent attention to detail, organization, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.

Qualifications

We are looking for applicants with:

• Associate’s degree in a scientific discipline or related field required; Bachelor’s degree preferred.
• 1–2 years of experience in a GMP-regulated pharmaceutical environment, preferably within documentation control or QC.
• Working knowledge of cGMP, GLP, FDA expectations, and data integrity principles (ALCOA+).
• Strong proficiency in Microsoft Word and Excel, with familiarity in controlled spreadsheets and formula validation.
• Excellent attention to detail, organization, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.

Skills

• Strong organizational and documentation skills.
• Familiarity with regulated laboratory environments.
• Understanding of compendial requirements that impact QC documentation and testing practices.

Benefits

• 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