Jamie Mcclellan Email & Phone Number

Decatur, Illinois, United States

Saxonburg, Pennsylvania, US

• Spearheaded project management initiatives using Microsoft, SQL, Oracle, and Agile, achieving a 10% year-over-year revenue increase by optimizing communication between sales and operations in my first year.
• Launched Agile and Oracle systems, drafted QSOPs enhancing site compliance and operational standards, and maintained ISO 9001 Certification, ensuring quality assurance.
• Cultivated relationships, facilitating communication of changes across legal, quality, engineering, and internal and external stakeholders, improving collaboration in the epitaxial growth domain.
• Ensured transparent communication of project plans and CAPAs across all levels, securing adherence to timelines and budgets within the custom epitaxial growth domain.
• Monitored regulatory requirements and industry standards, offering strategic insights to secure market share and advise on business impacts.
• Coordinate the scheduling and budgeting of production and maintenance resources, raw materials, and personnel, for 10 MOCVD tools.

Rahway, New Jersey, US

• Drive real-time quality assessments and scrutinize production activities and processes using, Quality Audits, GEMBA, and Lean Principles, delivering valuable feedback on proposed and executed corrections.
• Administer and support the SAP Investigation and CAPA Database, managing investigations within field complaint and non-conformance systems. Drive root cause identification and CAPA development.
• Promote successful customer and global regulatory audits/inspections (FDA, CMO, EMA, China) by providing and presenting actions and documents for auditors and authoring official responses.
• Lead project management initiatives for the introduction of new vaccine raw materials into the current formulary plant.

Lake Forest, IL, US

• Develop personnel across quality control, quality assurance, and operations. Oversee a team of sixteen (16) individuals handling Investigations, Complaints, CAPAs, and Regulatory Compliance documents
• Organized Annual Product Review (APR) for 70+ products, providing support for investigations, complaints, quality initiatives, and CAPA metrics
• Develop, Implement, and Administer the TrackWise Investigation and CAPA Database as Primary Administrator for four (4) Akorn sites and support administrator for four (4) additional locations
• Lead risk analysis processes (FMEA, SWOT, HHE) for Regulatory Submission Responses, Health Hazard Evaluation, Field Alerts, and Recalls at Decatur Facilities
• Host, prepare documents, and craft responses to Regulatory (FDA, Health Canada, NAFDAC, DEA, CMO, NSP, UL), Customer, and Internal Audits
• Serve as a liaison for CMO customers, addressing quality concerns and ensuring controlled document delivery as per Supply Agreements and Contracts.

Chicago, IL, US

• Manage laboratory personnel and equipment, ensuring safe and efficient operations for maximum capacity and performance, yielding high-quality products
• Plan, initiate, and execute capital improvement programs within the plant laboratory while maintaining budget oversight
• Develop and update documentation and validation documents, elevating the department to Q7A compliance and enhancing the training program's efficiency
• Implement a Competency Matrix to standardize QC personnel evaluation, utilizing SMART goals and establishing a mentor training program to expedite training for new and returning technicians
• Lead and support customer and global regulatory audits/inspections (FDA, ISO, HALAL, HACCP, CMO) within the laboratory, authoring and providing support documentation for quality laboratory observations
• Author and analyze metrics associated with the LIMS system, HACCP, and Out-of-Specification (OOS) excursions

• Conduct QA review of Bath Records, Raw Material, In Process, Initial Release, and Stability laboratory reports
• Maintain Quality Assurance for Stability, Technology Transfer, and Aseptic Intervention Monitoring and Validation Data Collection Systems
• Coordinate FDA monthly and lot-by-lot reports for pharmaceutical products, serving as Recall Coordinator for four simultaneous multi-distributor recalls
• Author and review protocols and validation reports within Quality Operations (QO) and adjacent departments
• Develop a framework for scheduling and tracking batch manufacturing for internal and CMO product lines, enhancing communication and predictability in product release timelines
• Support Regulatory (FDA, MHRA, Health Canada), Customer, and Internal Audits through preparation, SME interviews, and response coordination

US

• Responsible for the Quality Assurance review of Raw Material, In Process, Initial Release and Stability laboratory reports
• Decreased turnaround of all reviewed lab documentation by more than half while actual number of reviewed documents has increased by more than 100 percent in 2008.
• Developed a user friendly process to track aseptic interventions

• Coordinated monthly COPQ-Lab Performance Reports for the corporate office
• Spearheaded of quality control on all incoming chemical raw materials
• Lead Investigator for customer and internal complaints
• Author and Review SOP and GMP practices and documentation
• Utilizes traditional wet chemistry, FTIR, HPLC, and GC
• Maintain ISO 9001 Certification

Master Of Science (Ms), Regulatory And Quality Compliance

Inorganic Chemistry

Bachelor Of Science (B.S.), Chemistry