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14 days old

Quality Compliance Auditor / Regulatory Affairs â?? Los Angeles, CA

Kelly Services
Los Angeles, CA 90006
**Quality Compliance Auditor / Regulatory Affairs** Los Angeles, CA



**Job Duties and Responsibilities:**




+ 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 companys suppliers and contract laboratories. This may require approximately 10% domestic and international travel.

+ Coordinate, schedule and participate in audit activities associated with companys 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.



**Skills:**




+ 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 cGMPs.

+ 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.



**Job Requirements:**




+ A minimum of a bachelors 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.



**For immediate consideration, apply today!** Questions? Call Airika at 562-206-2707 or Email to airc843@kellyscientific.com






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-28 Expires: 2019-11-28

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Quality Compliance Auditor / Regulatory Affairs â?? Los Angeles, CA

Kelly Services
Los Angeles, CA 90006

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