Associate II, Quality (7pm-7am) Job at Baxter (Marion)

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

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
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)
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
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)

Requirements

High School Diploma, GED, or equivalent required. Must be at least 18 years of age
BS in engineering/science or equivalent work experience
3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry
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
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

Nice to have

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Flexible Spending Accounts
educational assistance programs
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits

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Associate II, Quality (7pm-7am)

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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