US-MD-Walkersville: QA Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 21-Aug-2008

QA Specialist

Your Role: Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. A wide degree of creativity and latitude is necessary.

# Primary Responsibilities: Verify the company's compliance with GLP/ISO/GMP quality system requirements and other regulatory guidance as appropriate. # Determine what would be required for the existing Quality System to comply with GLPs. # Review and approve GLP Study Protocol and supporting documentation. # Audit internal quality system elements in Quality Control, Vet Services and manufacturing areas. # Perform GLP phase audit and non conformances. # Provide oversight for compliance of CA/PA and investigations. # Perform external audits of suppliers/vendors/off-site facilities. # Act as a customer interface during on-site audits, conference calls and other standard means of communication. # Prioritize and manage a variety of projects simultaneously. # May need to lead and direct the work of others. # Perform review/release of batch records, as needed. # Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Your qualifications: # Bachelors degree in life sciences and 5-8 years of QA/QC experience required. Three years direct QA experience preferred. # GMP compliance and Part 11 compliance knowledge preferred. # Written and oral communication skills to include accurate and legible documentation skills;ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic. # Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects concurrently.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com