QA Quality System Specialist III

Nature and Scope

The Quality Systems (QS) Specialist III will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs.  This is a cross-functional position that interacts with all departments at American Regent. 

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines.  Identify trends, evaluate metrics and provide support for internal audits under the direction of the QS Manager.
  • Ensure Investigation and CAPA timelines are maintained through inter-department communication.
  • Facilitate and lead assigned high risk or complex investigations involving multiple investigation areas.
  • Review Quality Systems data for trends within department’s areas of support and report to functional area management, QA and QS Manager/Supervisor. Facilitate and participate in initiatives to identify and address trends.
  • Ensure appropriate corrective action plans are implemented and verified for effectiveness in accordance with company SOPs, policies and cGMPs. Facilitate ongoing progress to drive completion of CAPAs.
  • Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests.
  • Confirm the completeness, accuracy and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. 
  • Support functional area managers in internal audit response activities.
  • Provide support to Senior Management for all internal third-party audits.
• Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.  Collaborate with QS staff, colleagues, leadership to ensure that goals and objectives are accomplished in a timely manner.
  • Interact and maintain relationships with colleagues, investigators, and staff in facilitating department objectives and ensuring positive working interactions.
  • Provide detailed attention to carry out activities in support of the QS Department with inter-related activities of other programs, departments or staff and communicates within the appropriate timeframe.
  • Work independently and recognize daily needs to be met with minimal supervision while delivering timely results.
  • Develop, maintain, and facilitate applicable training around the Quality System processes and functions.
  • Effectively manage multiple tasks and work under pressure.

• Ownership of continuous improvement initiatives to improve the Quality System.
  • Identify and lead initiatives to continuously improve the Quality System.  Author and facilitate change requests as required.
  • Represent the QA group in continuous improvement committees or working groups.  Incorporate process improvement tools to guide working groups. Facilitate first pass acceptance of identified deliverables.
• Position has responsibilities at multiple locations in central Brea.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's Degree required. Quality certification preferred (e.g. ASQ).
• 5+ years of quality assurance experience in an FDA regulated environment required.
• Six-sigma yellow or green belt certification preferred.
• Demonstrated analytical and critical thinking skills.
• Knowledge of applicable FDA regulations and established expertise in interpreting and applying to the organization required.

• Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers.

• Direct experience investigating any issues that may occur during cGMP activities and summarizing investigations in written format is required.
• Demonstrable experience in root cause analysis, impact assessment, and risk management is required.
• Exceptional organization and time management skills. Proven ability to multitask efficiently.
• Detail-oriented person with the ability t