Aubree Jacobs Email & Phone Number

Longmont, Co, Us

Basel, Bs, Ch

• Acts as the primary CDMO contact for external customers regarding all quality-related activities and regulatory concerns, ensuring effective communication and alignment on compliance requirements.• Drafts, reviews, collaborates on, and approves product and process-related cGMP documentation to demonstrate regulatory compliance and control of manufacturing operations (CMC).• Oversees all quality-related change management and risk assessment activities, collaborating on, reviewing, and approving deviations, laboratory investigations, and CAPAs to evaluate quality and regulatory impact.• Develops, reviews, and presents quality-related metrics on a weekly basis to internal and external stakeholders for 7 commercial products, facilitating transparency and informed decision-making.• Demonstrates quality leadership and regulatory decision-making on cross-functional teams, including Manufacturing Operations, Supply Chain, Process Engineering, Quality Control, Quality Systems, and Safety.• Provides support for customer audits and regulatory authority inspections, maintaining up-to-date knowledge of current regulations and guidance impacting all aspects of contract manufacturing for commercial products.

San Diego, Ca, Us

• Established “phase-appropriate” requirements for regulatory compliance at R&D manufacturing site supplying materials for commercial products, ensuring alignment with standards and supporting inspection readiness.• Led and participated in internal audits across functions such as pharmacovigilance, product surveillance, and material quality to verify adherence to regulatory requirements and enhance departmental compliance.• Reviewed and issued all documentation related to in-process sampling, labeling, and controls, providing quality assurance oversight for all manufacturing floor activities and ensuring compliance in batch disposition of product.• Authored and reviewed technical documentation including SOPs, Master Batch Records (MBRs), and CAPAs, while facilitating compliance through the completion of Alert/Action Notifications, Deviations, Gap/Risk/Impact Assessments, and Change Controls.• Communicated quality systems metrics to leadership. Analyzed metrics for turnaround time (TAT) and managed records for open, closed, and overdue items to ensure continuous improvement in quality processes.

San Diego, Ca, Us

• Developed, reviewed, approved, and revised SOPs and work instructions to ensure regulatory compliance with quality system requirements.• Reviewed and approved controlled documents, corrected formatting errors, and ensured compliance with quality and regulatory standards. Communicated effectively with document owners to ensure timely completion of periodic reviews and addressed urgent business needs through prompt implementation of critical documents.• Managed EDMS migration to Veeva QualityDocs and Veeva QMS, providing daily user support as the Veeva Document Admin/EDMS SME. Troubleshot user issues within the EDMS and escalated configuration errors, while training over 50 employees on the newly implemented systems.• Tracked and archived more than 10,000 legacy documents. Led initiatives to mitigate fire damage to offsite records by evaluating document damage, acquiring purchase orders and quotes for restoration, and supervising the cleaning process to maintain data integrity and regulatory compliance.

Bothell, Wa, Us

• Performed the writing, routing, issuing, and approving of documents to successfully implement document control procedures and ensure regulatory compliance at new CDMO manufacturing site. • Developed and delivered training regarding document control processes and workflows within Trackwise. Developed and executed processes for issuing, distributing, and archiving controlled documents. Managed the digitalization and offsite archival of thousands of legacy documents. Ensured all records met ALCOA+ standards.

Atlanta, Ga, Us

• Served as the sole onsite Document Specialist, managing the preparation, issuance, distribution, reconciliation, and archival of several hundred physical forms, logbooks, batch records, material specifications, labels, and validation documentation each week. Established and maintained compliant filing systems for all paper-based GxP documentation.• Reviewed, routed, and approved documents within the EDMS to ensure alignment with regulatory requirements, proper formatting, and accurate metadata. Collaborated cross-functionally to ensure timely implementation of document change requests and adherence to regulatory standards.

Durham, North Carolina, Us

• Controlled the issuance, receipt, and archival of GxP documentation. Reviewed all documentation for compliance with Good Documentation Practices (GDP) and ALCOA+ principles.• Managed records in the EDMS and maintained paper-based controlled documents, ensuring all processes adhered to FDA and EMA requirements. Served as a qualified trainer in controlled copy and EDMS processes, successfully onboarding new employees within two weeks of hire to ensure training compliance.• Conducted thorough reviews of documents in the EDMS in preparation for collaboration with stakeholders from various functions, including technical, QA, and external customers, ensuring alignment with regulatory requirements. Acted as the lead on technical document review and preparation, facilitating compliance and quality assurance throughout the documentation process.• Fulfilled documentation requests from internal and external customers in a timely manner using a help desk platform, ensuring all communications adhered to regulatory expectations. Demonstrated exceptional communication skills in responding to requests, maintaining transparency and compliance.• Supported CDMO client audits and FDA regulatory inspections, including Pre-Approval Inspections (PAI) and for-cause inspections, ensuring all documentation and processes met regulatory requirements and facilitated successful outcomes.

Pittsburgh, Pa, Us

Pittsburgh, Pa, Us

Master Of Science - Ms, Regulatory Science

Bachelor Of Arts - Ba