Quality Associate I - Plastics, Baxter

Quality Associate I - Plastics

Baxter

Location:

United States, Marion

Category:

Quality Control

Contract Type:

Employment contract

Salary:

60000.00 - 90000.00 USD / Year

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Job Description:

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. Oversee daily departmental operations, improve processes, analyze data for trending, and develop corrective action plans. Work closely with other internal groups such as production supervisors and engineering to achieve quality outcomes.

Job Responsibility:

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)
Improve standard work processes to communicate between shifts, resolve nonconformance situations, and lead departmental tasks
Lead ongoing, daily departmental operations, including error correction, exception handling and document center support
Analyze data collected for trending purposes
Supervise assigned personnel to achieve quality goals in a timely manner
Perform in-depth internal assessments and evaluations by gathering and analyzing objective evidence regarding risks
Work closely with production supervisors, quality, engineering and other internal groups
Develop plans to correct identified risks including areas of non-conformance
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements
Write, review, analyze and revise Standard Operating Procedures (SOPs)
Oversee audits of various reports
Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead

Requirements:

Bachelor's degree preferred or equivalent experience within a manufacturing setting may be considered
Strong interpersonal skills and phenomenal 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 partnership 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:

Computer experience
Ability to interview/hire, evaluate, train and develop direct reports
Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices

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
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Flexible Spending Accounts
Educational assistance programs
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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