Senior Associate/Associate, Quality Assurance

Senior Associate/Associate, Quality AssuranceAt Eton, we search the world over for meaningful therapies that we can bring to patients living with rare diseases.Our locations in Deer Park, IL and Tampa, FL both currently have an opportunity for a Senior Associate/Associate, Quality Assurance. To apply for this position, you must be able to commute to one of the two offices. These roles are hybrid, requiring 3 days a week onsite.WHAT YOU’LL DO:Primary Job Function:The core job responsibility of the Sr. Associate / Associate, Quality Assurance, is to perform quality assurance activities, including training, document control activities, and support for quality events. This position will report to Director, Quality.Core Job Responsibilities:Quality Systems:Scheduling and general support for internal audits.Working with management to draft Quality Plan and monitor completion of quality objectives.Assist in implementation and maintenance of the Quality System according to applicable regulatory requirements.Scheduling and support for Quarterly Management Review Meetings.Support for mock recalls.Support for pharmacovigilance team with respect to any product complaint investigations.Document Control:Draft, maintain, and review Quality related documents (e.g., Policies, SOPs, Work Instructions, etc.)Issuance of NDCs, Medical Food Numbers, Product Codes.Management of Periodic Compendia Review.Assist in creation and management of Safety Data Sheets.Support reviews for Quality Events (Deviations, CAPAs, Product Complaints, etc.).Responsible for low impact change controls.Training Program:Working with management to draft employee training requirements.Ensuring Training Plans align with established training requirements.Training file updates – includes job description updates, job title changes, employee files, etc.Scheduling company-wide CGMP annual training.Support for onboarding and offboarding of employees.Supplier Program:Assist Quality Supervisor in scheduling supplier audits.Assist Quality team with approved supplier maintenance activities.Provide general support to the Quality team.QUALIFICATIONSUnderstanding of Quality Management Systems, CGMP regulations, and ICH guidelines.2-3 years of experience in a Quality Assurance role required.Bachelor’s degree in a Health Sciences related field.Good communication and technical writing skills.Ability to work independently with minimal oversight and direction.Ability to effectively manage and prioritize multiple tasks and projects.WHAT WE OFFER:Total compensation with salary and bonus is targeted for $75,000 - $100,000. Final pay determinations will depend on various factors such as geographical location, experience level, knowledge, skills, and abilities.Eton offers excellent benefits including:Competitive medical, dental, and vision coverage401K matchLife, LTD and STD insurance coveragesGenerous paid time off including vacation, sick time, and holidaysOpportunities for equity grantsAbility to participate in employee stock purchase programEton Pharmaceuticals is an Equal Opportunity Employer and will consider all applicants based on their job qualifications, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, or any other characteristic protected by federal, state or local law.