QA Lab Auditor

Company: Synerfac
Location: Newark
Posted on: May 28, 2023

Job Description:

QA Lab Auditor - Newark, DE$40,000-$50,000Summary:Will be responsible to audit and report each assignment to management to ensure their client services conform to applicable Good Laboratory Practices and Guidance Documents (FDA, OECD Principles, Japanese MHLW). Incumbent will perform duties with integrity and ensure all records and business affairs assigned to them are kept in a confidential manner (i.e., controlled, protected, and secured). Essential Functions: * Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOP(s), procedures and actual data results obtained during the study.* Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.* Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.* Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director and Management and verify their follow-up responses are adequate and complete to close the audit.* Assist with client and government audits or any department goals as requested by supervisor or managerEducation / Experience: *Bachelor's degree in Biology, Biochemistry, Immunology, Analytical Chemistry or other related scientific discipline Work Environment:This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Computers run on a Windows based operating system and proficiency with MS Office products, including Outlook, Word, Excel and PowerPoint, is required. If interested and meet the requirements, please send your most up to date resume to: ttoy@synerfac.comKnowledge / Skills / Abilities:-Ability to understand and comply with GLP regulations, principles and Guidance Documents.-Ability to anticipate and identify critical issues or problems and recommend solutions.-Demonstrates Life Sciences technical skills and the abilities necessary to achieve goals.-Effective verbal and written communication skills.-Proven ability to exercise good judgment and effectively balance work activities and changing priorities.

Keywords: Synerfac, Newark , QA Lab Auditor, Other , Newark, Delaware