Job Summary: Manages the Quality Assurance Unit (QAU) and related activities and functions to ensure compliance and overall quality, including planning, coordinating, and conducting various types of inspections and leading and implementing compliance improvement initiatives. This position may also serve in the capacity of document specialist in writing protocols and reports for non-regulated studies and providing support in the functional area of SOPs, methods and forms.

EDUCATION AND EXPERIENCE:

• Requires a Bachelors’ degree in Science or related discipline, plus at least 5 years’ experience in QA (preferably CRO)
• RQAP-GLP certification preferred

Job Qualifications: General Knowledge, Skills, and Abilities (KSA’s) required

• Proficient with Microsoft Office
• In-depth knowledge of FDA GLP and GCP requirements/guidance.
• Strong presentation and written/verbal communication skills.
• Critical thinking and decision making skill

Planning and implementing QA activities

• Develop and maintain Quality System/quality standards. Identify areas of non-compliance and advises company on risks and improvement.
• Apply in-depth knowledge of FDA GLP and GCP requirements and relevant guidance during daily activities and audits
• Present annual GLP training to staff
• Create, maintain, and/or update various controlled documents and other miscellaneous documents, including non-regulated study reports and protocols, SOPs, Forms, Methods, and Animal Use Protocols (AUPs), and Archival

Job Qualifications: General Knowledge, Skills, and Abilities (KSA’s) required

• Proficient with Microsoft Office
• In-depth knowledge of FDA GLP and GCP requirements/guidance.
• Strong presentation and written/verbal communication skills.
• Critical thinking and decision making skills

Physical Demands: Physical, Mental and workplace Environment Conditions

• Attention to detail and safety during audits/inspections. Standing and light lifting of up to 20lbs may be required.

Working Conditions: Workplace Environment Conditions

• Position functions are performed in an office and laboratory environment.