Documentation Associate

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

The Documentation Associate will support Quality Control operations by maintaining accurate, complete, and compliant documentation across the analytical data lifecycle. This role ensures analytical methods, specifications, controlled spreadsheets, and Empower calculations are properly created, updated, versioned, and archived in accordance with cGMP and data integrity standards. The ideal candidate will have strong organizational and documentation skills, familiarity with regulated laboratory environments, and an understanding of compendial requirements that impact QC documentation and testing practices.

• 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.

• 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.

• 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.