QA Compliance & Change Control Specialist

Nature and Scope

Reporting to the QA Compliance & Change Control Sr. Manager, the QA Compliance & Change Control Specialist focuses on facilitating Compliance and Change Control Processes at American Regent. This is a multi-disciplinary role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and material at all American Regent Sites in Ohio.

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.

• SOPs, Perform all duties in accordance with American Regent Business Principles, corporate directives, policies, and government and industry regulatory guidelines.
• Responsible for executing ARI’s Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements.
• Responsible for executing Customer Complaints Program in Ohio including metric reporting.  Works with functional areas to investigate and ensure timely closure of Customer Complaints.
• Responsible for assisting with Annual Product Reviews.
• Responsible for assisting with Corrective Action Preventative Actions (CAPAs).
• Participation in inspection readiness activities, including backroom support for regulatory and customer audits.
• Participation in internal audit activities.
• Assess the adequacy of submitted change controls.
• Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
• Responsible for the review and approval of change controls.
• Preparing monthly departmental metrics related to QA Compliance and Change Control processes.
• 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 in a Science related discipline is preferred.
• A minimum of 2 years of work experience in a Quality Assurance function or related field required.
• Experience working in pharmaceutical manufacturing or a GMP regulated environment preferred.
• Technical business writing experience required.
• Advanced computer skills to include Microsoft Word, Excel, Visio, PowerPoint, and Outlook.
• Knowledge of US regulations and experience in interpreting and applying to the organization is preferred.
• Strong organizational, interpersonal and communication skills (oral and written). Written skills must be  audit-level appropriate for non-routine or complex issues.
• Demonstrate ability to work effectively in a collaborative environment.
• Ability to work overtime as needed.
• Ability to travel between each of the Ohio facilities (in the greater Columbus area).

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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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.