Associate Quality Assurance Auditor
The role of the Associate Quality Assurance (AQA) Auditor is to support compliance with standard operating procedures (SOPs), study protocols, and Good Laboratory Practice regulations (GLPs). The Associate QA Auditor must demonstrate proficiency after training in audit procedures and adhere to proper documentation practices and QA policies and procedures. Including performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures; must use discretion and independent judgment in providing recommended corrective actions to specified QA lead.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Communicate all identified compliance and quality risks to supervisor.
• Assist auditors with data audits to assess that the records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
• Assist auditors with the review of SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and corporate policies and procedures.
• Prepare written and signed records of all audits and inspections as required and maintain records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
• Assist auditors with preparation for sponsor site visits and the review of QA files; assure that QA audit files are retained and archived according to procedures.
• Assist auditors in identifying, documenting, reporting deviations from regulations, protocols/batch records, SOPs, and specifications.
• Perform a preliminary review of protocols/batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
• Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
• Perform all other related duties as assigned.
Bachelor of Science (BS) degree in a science field (e.g., biology, animal science) is preferred or an equivalent combination of education and experience.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Education and Experience:
- 0 - 1 years' work experience in laboratory/research studies is preferred (this is an entry-level/training position)
- 0 - 2 years of GLP QA auditing is preferred
- Equipment/software validation experience is a plus
- Experience in immunotoxicology, toxicology, chemistry, biology or other related work
Knowledge, Skills and Abilities:
- Strong verbal and written communication skills
- Cooperate with coworkers in an organized team or work independently with minimal supervision
- Manage time effectively
- Basic computer skills (e.g., Word, Excel, PowerPoint, Outlook)
QA Compliant provides industry-leading audit, consulting, training, and advisory services to many of the world's leading pharmaceutical, biotech, agricultural, and life science companies. Clients count on QA Compliant to help them manage strategic operations by providing comprehensive customized solutions to our client's compliance, regulatory, and quality assurance needs. Through proven quality by design methodologies we effectively partner with our clients to minimize regulatory risk. QA Compliant specializes in FDA, EPA, OECD, ISO 9000, EU, and regulations with a focus of Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). www.QACompliant.com
QA Compliant offers a competitive compensation, great benefits, a flexible work schedule, and a casual working environment.
QA Compliant, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age.
Thu, 7 Sep 2017 10:30:18 PDT