Prinicipal Quality Assoc., Compliance

Clayton, NC, United States
Nov 03, 2020
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

The Quality Compliance Auditor will possess in-depth knowledge of cGMPs and have demonstrated application of robust Quality Systems. The Quality Auditor is recognized as an authority in multiple areas and able to independently develop and implement solutions for a variety of quality related objectives and influence the direction of complex projects. He/she will demonstrate consistent application of technical knowledge and expertise, execute assignments of medium to high complexity, and develop solutions for defined problems. This role will provide auditing, data analysis, review of failure investigations, coordinate component/commodity qualification (including coordination of material clearance testing), supplier management, coordination and/or review of purchase specifications/batch production records/standard operating procedures/quality agreements, author or review change control requests, review of manufacturing or testing reports, etc. Interactions by this position include collaboration within the GT Clayton site, other Grifols BioScience sites, suppliers/customers, and/or regulatory agencies. provides leadership and guidance to others. He/she will communicate with all levels of employees and may lead multi-discipline teams on projects of varying scope. As appropriate, this employee may serve as delegate to the department manager.

Primary Responsibilities for the Role:
  • Plan, schedule, lead, and execute, or otherwise participate in routine and directed internal audits utilizing knowledge of US and foreign regulations, guidances, and industry standards for pharmaceutical and medical device manufacturing
  • Review and analyze data, prepare and review reports; follow-up on observations and/or verify corrective action activities from previous audits; collaborate with manufacturing and QA/QC on corrective and preventive actions (CAPAs) associated with internal or external audits or other sources, projects, incident investigations, and change controls, for improvement of Quality Systems, etc.
  • Support site regulatory and customer audits, perform audit follow-up activities by requesting responses, tracking corrective actions and implementation status.
  • May also lead/participate in supplier management external audits and other supplier quality activities; author, edit, and/or publish SOPs, BPRs, purchase specifications, and other documents as directed using company prescribed computer software and systems.
  • Performs routine surveillance of current regulatory changes and expectations and incorporates them into the working operations of the company.
  • May be responsible for training other employees and is a fully qualified professional who requires minimal supervision.
  • Perform other duties as assigned by Quality Compliance management.

Knowledge, Skills and Abilities:
  • Excellent communication skills (written and verbal) with basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

Education/Experience Requirements:
  • BA/BS required preferably in a STEM (science, technology, engineering, or mathematics) curriculum

  • 5 - 8 years relevant experience
  • Must possess current ASQ auditor certification: Certified Quality Auditor`(CQA), Certified Biomedical Auditor (CBA) or equivalent auditor certification from a recognized professional certification authority.
  • Must possess adequate proficiency in the use of Word and Excel computer software.
  • Working knowledge of SAP functionality is desirable.

Work Hours:

This position is routinely scheduled to work Monday through Friday for an 8-hour interval during dayshift. Work on other shifts or days may be required and/or assigned for specific periods by management, including the requirement to travel during non-dayshift hours for work-related projects/duties. Overtime may be required as needed.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.