|Successful candidate will be responsible for scheduling, planning and conducting internal and external audits according to cGMP, GLP and GCP (GxP) regulations, ICH guidelines and VaxInnate standards. This position will also be responsible for training of personnel with respect to GxP and other applicable regulations.
Primary Job Duties Include:
• Perform all functions related to internal and external auditing in compliance with GxP regulations. At a minimum this includes planning and scheduling audits, sending confirmation letters, creating audit agendas, conducting audits and hosting audits, issuing audit reports, ensuring responses to observations are resolved, issuing audit verification certificates and maintaining auditing files.
• Develop a training program to ensure employees stay current with respect to GxP regulations and VaxInnate standards and are able to perform their functions efficiently, effectively and with high quality. This includes maintaining training files, scheduling, and conducting training of company personnel.
• Maintain, track, and trend all compliance activities with regards to Deviations, Amendments, Non-Conformances, Retests/Invalid Assays, Investigations, OOS (Out of Specification) and CAPAs (Corrective and Preventative Actions).
• Assist with review and approvals of documentation, such as analytical procedure records (APRs), reports, and raw data, ensuring compliance with protocols, Standard Operating Procedures (SOPs), Manufacturing Batch Records, Analytical Methods, and applicable GxP regulations.
• Identify deficiencies, provide and implement effective solutions to compliance issues in effort to improve the QA Compliance Program
• Other duties as assigned.
• B.S. degree in Chemistry, Biology, or related field with 5-8 years demonstrated practical experience in auditing GMP, GLP, and GCP facilities for the biotech/pharma industry;
• Thorough knowledge of cGMP, GLP, GCP and regulatory requirements is a must. Experience in auditing biotech manufacturing facilities is a plus;
• Previous experience conducting employee GxP training
• Must be able to travel to sites for overnight trips either by plane or car.
• Strong attention to detail and excellent verbal and written communication skills.
• Local candidates only who are legally eligible to work in the United States.
* Experience in conducting site visits independently;
* Must be available to travel by car or air domestically for overnight trips up to 30%
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