Nature and Scope

The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and Preventive Actions (CAPAs) and associated effectiveness checks are executed in compliance with company SOPs, internal policies, and applicable cGMP requirements. This role also supports the customer SNCR process, regulatory audit activities, and the Quality Council process. This is a cross-functional position that collaborates with all departments across American Regent. The incumbent will actively participate in planning, implementing, and maintaining quality systems to meet or exceed the company's quality standards and regulatory expectations.

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.

• 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, and leadership to ensure that goals and objectives are accomplished in a timely manner.
  
  • Interact and maintain relationships with colleagues, investigators, CAPA owners 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 interrelated activities of other programs, departments or staff and communicate within the appropriate timeframe.
  • Work independently and recognize daily needs to be met with minimal supervision while delivering timely results.
  • Effectively manage multiple tasks.

• Ensure any Corrective / Preventative Actions and Effectiveness Checks associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated, written and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify issues, evaluate metrics and provide support for internal audits under the direction of the QA Supervisor.
  
  • Ensure CAPA and Effectiveness timelines are maintained through inter-department communication with escalations as necessary.
  • Facilitate meetings to drive aging CAPAs and Effectiveness Checks to completion.
  • Review of Quality Systems data and metrics for trends within assigned area of support and report to QA Manager.
  • 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.
  • Complete monthly metrics for CAPA and Effectiveness Checks.

• Additional Quality System Support
• Support inspection readiness for regulatory inspections and internal or third-party audits.
• Provide support for customer Non-Compliance reports received (SNCRs).
• Support Quality Council and Management Review meetings, including preparation and follow-up activities.
• Participate in cross-functional training with the QA Deviations team as needed.
• Participate in continuous improvement initiatives to enhance the Quality System.
  
  • Identify and participate in initiatives to continuously improve the Quality System.
  • Represent the QA group in continuous improvement committees or working groups.
• 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 in a science or engineering discipline required.
• 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.

• Strong analytical, critical thinking, and problem-solving skills.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to effectively present information to top management, employees, or customers.

• Demonstrate experience in CAPA writing, documenting issues, 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 organizational and time management skills with the ability to effectively manage multiple tasks.

• Detail-oriented with the ability to work independently and collaboratively in a team environment.
• Computer skills to include Microsoft Word, Excel, PowerPoint, preferred.

Expected Salary Range:

$80,000 - $95,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.