QA Quality Systems Specialist I

Nature and Scope

The Quality Systems (QS) Specialist I 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.
• Ensure Investigation and CAPA timelines are maintained through inter-department communication.
• Facilitate assigned investigations involving multiple investigation areas.
• Review Quality Systems data for trends within assigned area of support and report to QS Manager.
• Ensure appropriate corrective action plans are implemented and verified for effectiveness in accordance with company SOPs, policies and cGMPs.
• Participate in initiatives to address compliance gaps identified during investigations with assistance from department manager. 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.
• Provide support to Senior Management for all internal third-party audits.
• Other duties may be assigned.
• 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.
• Effectively manage multiple tasks and work under pressure.
• Participate in continuous improvement initiatives to improve the Quality System.
• Support initiatives to continuously improve the Quality System.
• Support the QS group in continuous improvement committees or working groups.
• Position has responsibilities at multiple locations in central Ohio.
• 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.

• High School Diploma required. Bachelor's Degree preferred.
• 1 year of quality assurance experience in a regulated environment is preferred.
• Demonstrated analytical and critical thinking skills.
• Knowledge of applicable FDA regulations and experience 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.
• Exceptional organization and time management skills. Proven ability to multitask efficiently.
• Detail-oriented person with the ability to work independently, accurately and assess priorities.

• Ability to respond quickly to problems or changes in priorities and work with a team to effect solutions, sense of urgency.

• Ability to work in a team environment. Ability to work in multidiscipline environments.

• Basic computer skills to include Microsoft Word, Excel, Access, Visio or comparable software, PowerPoint, email.

• Self-directed requiring minimal supervision; urgency, and attention to detail and problem solving.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.