Amy Serabia Email & Phone Number

Seattle, Wa, Us

Seattle, Wa, Us

Oversee and maintain GMP Quality Systems operations by completing analysis, trending, identifying issues, and providing recommendations to ensure compliance. • Oversight of the Quality Systems, including Nonconformances, CAPA, Product Complaints, Investigations & Change Control Program, and performance of Management Reviews. • Managed Supplier Qualification Programing using a risked based system, including oversight of the external audit program. • Oversight of the GMP/GCP Training Program. • Support of regulatory inspections including logistics, planning, and preparation.

Seattle, Wa, Us

• Review executed (paper and electronic) batch records to ensure compliance with GMPs and approved procedures within product disposition timelines.• Foster a Quality culture with direct and frequent communication to Manufacturing (MFG).• Perform facility walk-throughs and created, generated metrics to provide to Management.• Review and approve incoming raw materials, maintenance, and calibration records for equipment.

Paris, France, Fr

Oversaw the performance of raw material suppliers and subcontractors by completing analysis, identifying issues, and providing recommendations to ensure compliance. • Launched significantly expanded subcontractor oversight including on-boarding and life cycle management by creating new procedures, providing customers assistance, monitoring, and providing metrics. Strengthened the site’s Quality Systems assuring inspection readiness.• Streamlined complaint (SCAR) process and reduced closure time by 40% allowing materials to be released more quickly allowing resources to be more efficiently used, freeing up warehouse space, and personnel time.• Developed and owned the Supplier Management Team (SMT) at site. Coordinated, collected, and presented monthly metrics, organized, and ran monthly meetings. SMT exposed potential material, service, and supplier issues allowing impacted groups to review metrics together, and observe areas of strengths and weaknesses.• Acted as liaison between Owners, Corporate, Legal, Subcontractors, Suppliers, and Consultants to initiate, negotiate, and complete 40+ Quality, Business, Confidentiality, and Change Notification Agreements. Worked to develop great relationships and communication during negotiation leading to a faster completion and more positive experiences.• Processed change notifications for the site (minimum of 100 change notifications annually) including determination of impacted materials; worked with owners to determine impact, follow-up, and tracked change to completion within 30-day target. • Performed periodic on-site business reviews with suppliers including analysis of metrics, creation of scorecard, presentation of review to suppliers, generation of corrective actions, and follow up/tracking of items for improvement. Periodic reviews led to significantly improved supplier relationships and communication, resulting in better reliability.

Leverkusen, North Rhine-Westphalia, De

Completed specialized QC projects and provided support to QC regarding any complex projects. • Evaluated FDA guidance for melamine/cyanuric acid, assessed materials used at the site, prepared risk assessment, and implemented at the site.• Coordinated raw material testing for the site including protocol/contract review, obtaining PO’s, created sample requests, oversaw shipments, received data, and communicated with contract labs and QC.• Managed and performed 20 QC subcontractor qualification, requalification, and quality agreements.

Leverkusen, North Rhine-Westphalia, De

Managed a QC laboratory for the support of a commercially produced, FDA approved drug.• Supervised a staff of eight employees.• Managed various QC programs including facilities testing, product release testing, environmental excursion program, equipment preventive maintenance program, and LIMS database.• Worked effectively with other groups such as Quality Assurance, Manufacturing, Engineering, Validation, and Regulatory Affairs.• Participated in and supported FDA inspections and internal compliance audits.

Leverkusen, North Rhine-Westphalia, De

Formerly Berlex Laboratories.QC Microbiology Associate I and Associate II.• Led various environmental, utility, and product investigations.• Scheduled laboratory tasks for a staff of six for two years.• Implemented and validated new technology and methodology within the QC laboratory as well as facilitated group training.

Thousand Oaks, Ca, Us

Formerly Immunex Corp.Quality Control Microbiology - Analyst I, Analyst II, Senior Analyst, and Associate I • Sampled and tested environmental/utility systems including bioburden, endotoxin, and particulate monitoring.• Skilled in various microbiological techniques and assays including Gram staining methods, aseptic technique, microbial identification, and reagent/standard preparation.