Associate I, Quality

What you'll bring

• Bachelor's degree strongly preferred.  Degree in engineering or science preferred.
• Must be at least 18 years of age and possess a High School Diploma or GED.

• 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 as appropriate.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

• 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.
• 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.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned. Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)