Operations & Compliance Documentation Specialist

Ashley Heinen

https://www.linkedin.Professional ashkheinen@830-com/Harper, 221-in/gmail.ashley-Summary 8458 TX com heinen-80857b186/ Manufacturing manufacturing, leadership. and documentation Validation, compliant Recognized and Master supporting solutions Engineering, Experienced Batch for professional driving lifecycle quality complex Record while continuous systems, management. Process in GMP authoring, maintaining change with operations. technical Science, 8+ management, improvement years risk Proven data assessments, Purchasing, documentation, of integrity experience ability deviation initiatives, and to and audit partner in regulatory Supply and and GMP-managing readiness, cross-investigation across regulated Chain compliance. functional competing Manufacturing, and to implement biologics quality support, project priorities, SOP QA, Core Competencies

• • • • • • • • • cGMP Quality Change Document CAPA Investigation Root Risk SOP / Assessments Cause & WI & Systems Control Deviation FDA / Control MBR Analysis Compliance Support Management Authoring Support

• • • • • • • • • Technical Audit Cross-Training Process Data SharePoint Microsoft ERP/Integrity SAP Readiness Functional Improvement & Exposure Office Writing Mentoring Suite Leadership Professional Experience

Velocity Bioworks – Team Lead, Manufacturing

• • • Lead Engineering, documentation Author and Support controlled cross-and Change functional revise Process GMP improvements. Control SOPs, documentation Science, quality Work implementation initiatives and Instructions, Supply supporting involving through Chain Master commercial to document Manufacturing, implement Batch Records, manufacturing. revisions, compliant QA, Technical Validation, risk process assessments, Reports, and

• equipment Partner with changes, QA on investigations, material updates, deviations, and cross-CAPAs, functional and corrective review coordination. actions to maintain

• GMP Coordinate compliance. document review cycles across multiple departments while maintaining project timelines and regulatory expectations.

• • • Support activities, Train documentation Lead continuous manufacturing equipment and technical and improvement qualification, procedures. personnel investigations. initiatives and cleaning serve that as validation a improve subject documentation, matter documentation expert for commissioning quality, GMP compliance, and operational efficiency.

Scorpius BioManufacturing – Manufacturing Leadership Roles

• • • • • Supported Authored compliance. Participated implementation. Collaborated improvements. Represented controlled implementation in Manufacturing with deviation QA, GMP Validation, investigations, documentation of during quality Engineering, client systems root audits supporting cause within and and analysis, Process internal GMP manufacturing manufacturing Development and quality corrective and reviews. quality on operations. action process

• • • • • • • • • • • • • • Deviation Change CAPA Investigation GMP Controlled Master Risk Equipment Documentation Audit Cross-Training Document Assessments Documentation Preparation Ownership functional Batch Control Documentation Management Revision Document Qualification Ownership Record Quality Management Development Lifecycle Review Quality Systems Experience