Audrey Cunningham Email & Phone Number

United States

Longmont, Co

Longmont, Co

Boulder, Co

Quality oversight of development, clinical product manufacturing. Product disposition and oversight of contract partners with respect to quality issues, deviations, investigations, CAPAs, validation, change control and product complaints. Manage and coordinate preparation of audits at contract facilities ensuring compliance with applicable regulations and contracts in accordance with industry standards. Responsible for the implementation of Quality Systems at ARCA biopharma.

Longmont, Colorado

Quality assurance contact for the following systems/programs: clean and plant utilities, changeover, area startup/shutdown, facility cleaning, gowning, pest control, Building Management System (BMS)/alarm response, CIP/COP systems, walkthroughs, facility drawings.• Reviewed and approved documents but not limited to: requirement documents, design documents, nonconformances, SOPs, project plans, validation plans, validation protocols/reports. • Responsilbe for IS business, computer, automation and manufacturing systems.• Reviewed and approved completed software configuration and testing documentation.• Served as QA contact for: change control records, projects, nonconformances/deviations, corrective/preventive actions (CAPA), and risk assessments.• Represent the department on various teams; managing existing or developing and implementing new programs, projects, processes and methodologiesRegulatory Assessor• Coordinated site-specific change control regulatory assessments with input from CMC product teams and CMC Regional representatives.• Regulatory Assessor CMC Representative on product deviation teams.

Colorado Springs, Colorado Area

Ensured studies performed under FDA, EPA, GLP and cGMP were in compliance with all applicable regulations as well as Standard Operating Procedures in support of NDA/IND and ANDA filings.• Supervised Quality Assurance personnel• Authored responses to regulatory and client observations• Led FDA audits, EPA audits and multiple client audits• Provided regulatory updates and guidance to other staff members and provided annual regulatory training for 25+ employees.• Trend deviations, corrective and preventative actions and report findings to management.• Implemented Corrective and Preventative Action (CAPA) program and vendor audit program.• Conducted vendor audits, performed audits, and oversaw internal auditing program.• Reviewed and approved Protocols, SOPs, deviations, investigations and validation (IQ/OQ/PQ).• Responsible for archiving, document control, change control and validation program for computer, software and laboratory equipment.

On Site At Amgen, Co

Ensured quality of data produced in laboratories by performing data review, auditing laboratories, and reviewing written procedures • Coached and developed Lancaster Laboratories staff to ensure cGMP compliance orientation and understanding• Provided annual cGMP training to Lancaster employees• Provided leadership for continual improvement of the Quality Assurance department

Rensselaer, Ny

• Participated in FDA audits as a scribe and performed internal audits.• Authored and reviewed SOPs, deviation reports/investigations and batch records .• Collaborated with various departments throughout the company to resolve corrections in batch records and test data .• Reviewed and prepared stability data for Biological License Application (BLA) submission.• Responsible for review and approval of raw material and product data prior to release.• Worked closely with Merck to resolve quality and process control issues.

Emeryville, Ca

Manufacturing Associate III • Purified HCV, HBV, HTLV, and HIV antigens to be utilized in ELISA and RIBA diagnostic kits using a variety of purification techniques• Coordinated with QC, QA, Bulk Fill and Process Transfer to complete purification and validation batches• Member of Chiron’s internal ISO-2000 audit team and participated in FDA audits during laboratory tours Quality Control Associate II Lead role as part of a quality control team which tested in-process samples from nearly 20 different protein purification processes (includes licensed and non-licensed products, as well as developmental products)• Responsible for training new staff and planning bi-weekly work schedule

Bs, Biology, Biology, General

Bachelor'S Of Science, Biology