Quality Compliance Auditor
Los Angeles Metro Area, CA
Conduct internal cGMP audits, conduct domestic and international supplier audits, write audit reports, write summary reports including (trends, tables, graphs, slides), participate in the audit response and corrective action process, verify implementation of corrective actions, write and revise documents and procedures.
Conduct training on procedures, cGMP, industry standards and practice and technical training as appropriate.
Hold and attend meetings.
Give presentations, verbal and audio-visual.
This position will interface with others inside and outside the company up to the VP level.
Will participate in customer audits, third party audits and national or international regulatory agency audits.
Coordinate, schedule and participate and/or perform internal cGMP and GLP compliance audits of the manufacturing, quality control testing, and warehouse facilities and operations.
Coordinate, schedule and participate and /or perform cGMP and GLP compliance audits of company s suppliers and contract laboratories. This may require approximately 10% domestic and international travel.
Coordinate, schedule and participate in audit activities associated with company s customers.
Participate and assist in the activities associated with regulatory inspections.
Play an active role in the development, coordination and presentation of training programs within the areas of responsibility for the department and for others.
Writes and revises documents and procedures relevant to the auditing function.
Issues audit reports, assist as required in the audit responses, verify the implementation and evaluate the appropriateness of corrective actions.
Assist in other departmental activities as determined by the department manager.
Provide scientific and/or technical advice and counsel regarding projects as needed.
Participate in regulatory and internal inspections/audits including providing written responses as applicable.
Maintain current knowledge of regulatory and industry standards, trends and advancements.
Experience in the Pharmaceutical, Biologics, Medical Device or other Health Care industry is also required.
Certification in industry auditor training programs, such as (ASQ, RAPS, ISO etc.) is preferred.
Working knowledge and understanding of concepts of cGMP and GLP.
Understanding of industry standard operational/manufacturing practices.
Knowledge of US and international regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products.
Computer literacy with proficiency in MS Word, Access, and knowledge of Excel and PowerPoint.
Able to work independently with minimal supervision.
Willing to travel as needed, domestically and internationally, with overnight stays from one to two days to up to two weeks.
Able to adhere to Manufacturing and QC Laboratory gowning and safety procedural requirements.
This position requires frequent gowning in-order to support audit activities in the environmentally controlled facilities during internal audits, customer audits, regulatory audits and supplier audits.
Thorough knowledge of USA FDA, EU and international cGMP s.
Project management experience is preferred.
Excellent verbal and written communication. Must be able to read, write, and speak English.
Well-developed communication skills especially in stand-up presentation or facilitation.
Good negotiations skills.
Must have strong technical writing skills.
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
A minimum of a bachelor s degree in one of the Life Sciences, Health Care or other Science or Engineering discipline.
Minimum of 2 years of experience in Regulatory Compliance, Regulatory affairs, Quality Engineering, Quality Control or Quality Assurance conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers.