Experience

Aragen Bioscience, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• QA/QC Manager

  • Feb 2016 - Present

• QA/QC Manager

  • Feb 2016 - Present



ISIS Services

• Director of Operational Compliance

  • Jun 2012 - Dec 2014

  As head of the RA/QA Department, my main duty is to ensure compliance to internal and external requirements as a licensed research facility. This means assuring federal, state, and local requirements are met (USDA,FDA, NIH, DEA, CDPH, San Mateo County) through audits by these agencies as well as clients. I also represent ISIS during audits for GLP purposes and a member of the QAU. I am responsible for maintaining the Quality Program, Document Control, and Archiving. In addition, I continue to lead efforts towards maintaining AAALAC Accreditation via coordination of site visit and involvement in the inspection and review process. With an emphasis on SOP and Quality, I provide in-house training for IACUC, GLP, EH&S, among other topics. With Facilities as a direct report, I work daily with the department to ensure the physical plant and key equipment are monitored and in working order according to SOP. Finally, I back-up for the management team as needed.

• Director of Operations

  • Nov 2007 - Jun 2012

  Responsible for day-to-day operations for a 22000 sf training and research facility; work with professional staff to assure resources are available for research areas, including facilities, administration, project management, RA/QA, and husbandry; provided key business indicator reports and in-house sales quotes; along with veterinary and technical staff,meet with potential clients to discuss projects; chair of IACUC; EH& S committee member; basic HR functions; develop and implement local policies and procedures (Occ Health, IACUC, HR, etc.); assure all regulatory requirements are met at city, state, and federal level. Spear-headed AAALAC Accreditation efforts and achieved accreditation status 2008.



U.S. Department of Veterans Affairs

• United States
• Government Administration
• 700 & Above Employee

• Supervisor, Program Specialist (VMU)

  • May 2002 - Nov 2007

  Oversight of operations for research facility, developed and implemented local policy and practices such has training programs and new database for tracking use and invoicing. Worked with a staff of 8 technicians on site, also held position as administrator for R & D subcommittee, working along other subcommittees to reviewa and approve research proposals; coordinated meetings, conducted site audits and responsible for maintaining accreditation status Oversight of operations for research facility, developed and implemented local policy and practices such has training programs and new database for tracking use and invoicing. Worked with a staff of 8 technicians on site, also held position as administrator for R & D subcommittee, working along other subcommittees to reviewa and approve research proposals; coordinated meetings, conducted site audits and responsible for maintaining accreditation status



Covance Ressearch Products

• RA/QA Manager

  • Mar 1998 - May 2002

  Responsible under RA/ QA for IACUC and GLP studies for west coast site of CRP; this included assuring all regulatory requirements were met for local, state and federal agencies (city, Radiologic Health Branch - CA; DEA, FDA, USDA, NIH, etc) Conducted internal quality audits to maintain compliance; participated in client and agency audits routinely; achieved ISO 9002 status; adminsitrator for IACUC and responsible for all protocol review, client correspondence, documentation needs. Responsible under RA/ QA for IACUC and GLP studies for west coast site of CRP; this included assuring all regulatory requirements were met for local, state and federal agencies (city, Radiologic Health Branch - CA; DEA, FDA, USDA, NIH, etc) Conducted internal quality audits to maintain compliance; participated in client and agency audits routinely; achieved ISO 9002 status; adminsitrator for IACUC and responsible for all protocol review, client correspondence, documentation needs.



Berkeley Antibody Company (BAbCO)

• RA/QA Coordinator

  • Mar 1997 - Mar 1998

  Supported RA/QA Department for two sites; member of QAU; conducted all regulatory agency audits, client GLP audits, and internal quality audits, administrator for the IACUC, supported training programs, provided general administrative support Supported RA/QA Department for two sites; member of QAU; conducted all regulatory agency audits, client GLP audits, and internal quality audits, administrator for the IACUC, supported training programs, provided general administrative support