Quality Assoc II
- Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.
- Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
- Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
- Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
- Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance.
- Inform management and implement approved corrective action plans. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
- Provide training and coaching to local employees and others as needed on relevant area(s).
- When required, assist other Quality areas in the successful performance of these activities. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills
- Support process with timely closure of observations/audit items.
- Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
- Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead.
- Other duties, tasks or projects as assigned.
Qualifications for this role
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving, and good verbal and written communication skills.
- Must have the ability to manage people, encourage teamwork and drive decisions.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and application of Good Manufacturing Practices.
Education & Experience
- BS in business/science or equivalent.
- 3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.
A Career that Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.