QA Associate - Pharmaceutical Analysis **$1000 SIGN-ON BONUS**

53704 Job posted on: 4/18/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us!  Covance offers a FULL BENEFITS program that starts day 1, relocation assistance and excellent CAREER GROWTH opportunities - while making a difference in the lives of millions.  We provide full training and at least $14.50/hr with additional wage credit for experience. ASK US ABOUT OUR $1000 SIGN-ON BONUS FOR QA ASSOCIATES!  Job Summary: Verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations by performing internal protocol, data, report, in-lab phase inspections, and supplemental audits. Cross-site support may also be provided for a technical discipline or specialized function. Responsibilities may include co-hosting client audits, and supporting process improvement activities and cross-site harmonization efforts. Duties and Responsibilities: • Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable. • Performs internal supplemental audits of a technical discipline to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements. • Performs internal protocol, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOP and regulatory requirements. • Ensures systems used in QA are properly maintained (e.g., QA audit records, training records). • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution. • Ability to support a second auditing discipline, same auditing discipline cross-site, or specialized function (e.g., document control of SOPs/P&Ps, provide application support for site training/ testing, provide training to new auditors, provide regulatory training). • Participates in client introductions, tours, and client audit debriefs. • Co-hosts client audits by assisting host with preparation for audit, and by assisting the client with review of study data and facility records. • Assists with regulatory inspections as needed. • Notifies management of observed quality/compliance trends and service failures. • Completes assignments/projects designed to support process improvement opportunities and harmonization efforts to promote best practices. • Peer reviews SOPs, policies, training materials, and other documents for recommended changes. Experience: • One year of experience as a Quality Auditor in a research lab is required with a BS/BA degree. cGMP experience in a lab environment is preferred. Education: • Bachelor of Science/Arts (BS/BA) degree • Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint). • Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |