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.

For more information, please write to us.

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