Quality Associate IIIReq # JR - 021205 Location Marion, North Carolina, United States Job Category Quality Control Date posted 06/18/2020
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Responsible for quality assurance review of investigations and corrective and preventative actions across a department or functional area. Responsibility includes ensuring timeliness of the investigation and review process, root cause identification adequacy, compliance with good documentation practices, mitigation and containment strategies, and approval of appropriate Effectiveness Plans for the actions identified, including effectiveness criteria and timeframe. A functional understanding of FDA, ISO and Baxter Quality systems is required.
Essential Duties and Responsibilities
- Perform quality approver review of investigations providing guidance to investigators on root cause investigation adequacy and regulatory compliance
- Promotes standardization of investigations within the department and appropriate use of investigative tools to determine root cause
- Ensures adequate identification of corrective and preventative actions aimed at minimizing or eliminating nonconformance recurrence
- Measures process performance metrics to drive investigation improvement and compliance
- Works closely with investigators to facilitate timely closure of investigations and CAPA; responsible for meeting product release commitments
- May interface directly with FDA and other external and internal inspectors to present investigations and associated corrective and preventative actions
- Ensures adherence to all SOPs, policies and procedures, including any department specific requirements
- Ensure investigations follow the CAPA procedure, including all investigation element requirements per local and corporate procedures
- Learn, understand and apply rigorous quality standards and Current Good Manufacturing Practices (cGMP)
- Sustain a clean and safe work area using 6S principles
Knowledge, Skill and Abilities
- Strong knowledge of applicable procedures, specifications, regulations and standards. Experience interpreting and complying with cGMP within a pharmaceutical manufacturing environment.
- Strong analytical and problem solving skills with applied experience in root cause determination and utilization of root cause tools.
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Experience in performing or reviewing chemistry and / or microbiology nonconformance investigations is desirable
- Understand verbal and written 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.
- Requires a bachelor’s degree, from an accredited institution, preferably in a scientific or technical discipline.
- 4-8 years of experience in quality assurance role in a manufacturing environment in the pharmaceutical, biotechnology, medical device or comparable field.
Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.
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.
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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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.