The QA Specialist 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. The incumbent will participate in planning and organizing the quality systems to meet or exceed the company's quality expectations.

Essential Duties and Responsibilities

• Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Collaborate with QA 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 QA 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.

  • Effectively manage multiple tasks.

• 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 QA Deviations Supervisor.

  • Ensure deviation timelines are maintained through inter-department communication.

  • Facilitate and lead assigned investigations involving multiple investigation areas.

  • 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.
    

• Participate in continuous improvement initiatives to improve the Quality System.

  • 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.

Education Requirements and Qualifications

• Bachelor's Degree or 8 years' experience in QA/QC in regulated environment, required.

• 2-5 years of quality assurance experience in a regulated environment, required.

• Knowledge of applicable FDA regulations, and experience in interpreting and applying to the organization, required.

• Experience investigating and documenting issues that may occur during cGXP activities, preferred.

• Experience in root cause analysis, impact assessment, and risk management.

• Understanding of how the pharmaceutical process pathway works, specifically how each of the various disciplines interact with each other.

• Exceptional organization and time management skills and ability to multitask efficiently.

• Must possess analytical and critical thinking skills.

• Detail-oriented with the ability to work independently.

• Ability to work with cross-functional groups and in a team environment.

• Computer skills to include Microsoft Word, Excel, PowerPoint, preferred.

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