<p>The Position</p> <p>This position will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.</p> <p>Responsibilities</p> <ul> <li>Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions). </li><li>Convert SME input into clear root cause documentation aligned to evidence. </li><li>Write CAPAs linked to root cause, including action plans and effectiveness checks. </li><li>Draft change controls (rationale, scope, impacted areas/docs, implementation plan). </li><li>Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence). </li><li>Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records. </li><li>Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations. </li><li>Support audits/inspections by quickly clarifying or revising QMS narratives as needed. </li></ul> <p>Requirements</p> <ul> <li>BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry </li><li>3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations. </li><li>Proficient experience working with controlled documentation </li><li>Experience with internal CAPA investigations </li><li>Proficient project management skills </li><li>Ability to collaborate with and coordinate cross-functional teams </li><li>Proficiency with Microsoft Suite applications (Word, Excel) </li><li>High attention to detail </li><li>Ability to multi-task and manage responsibilities within ongoing projects </li></ul> <p>Preferred</p> <ul> <li>5+ year's GMP experience and 3+ cGMP deviation and/or change control experience </li></ul>