Quality Associate III
About The Position
At Baxter, colleagues work toward the mission to save and sustain lives, guided by a culture of courage, trust, collaboration, ownership, and accountability. The position description identifies the role as a Senior Quality Investigation Lead. The role serves as a subject matter expert in Baxter’s Quality-led investigation program, independently leading high-risk, systemic, recurring, and cross-functional investigations. The role partners with leaders and technical experts to evaluate evidence, assess product impact, determine root causes, and develop effective corrective and preventive actions. It also strengthens the investigation program through coaching, case calibration, continuous improvement, and identification of broader quality trends. The role calls for navigating ambiguity, challenging assumptions, and communicating complex technical findings to support objective, defensible quality decisions aligned with patient safety and regulatory expectations.
Requirements
- Bachelor’s degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; an equivalent combination of relevant regulated-industry experience may be considered through an approved equivalency process.
- 5+ years of progressive experience in pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
- 3+ years of experience leading formal investigations, including ownership of complex, recurring, systemic, or high-risk quality events.
- Expertise in cGMP regulations, Good Documentation Practices, quality risk management, CAPA systems, data integrity, and investigation methodologies.
- Ability to evaluate complex technical evidence, conduct product impact assessments, determine defensible root causes, and develop sustainable corrective and preventive actions.
- Strong technical writing, analytical reasoning, facilitation, project leadership, coaching, and conflict-resolution skills.
- Experience communicating technical and compliance-related information to senior leadership, auditors, inspectors, and cross-functional stakeholders.
- Proficiency with electronic Quality Management Systems (eQMS), such as TrackWise, and data analysis or reporting tools.
- Must be authorized to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa at this time.
Nice To Haves
- Advanced degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline.
- Experience defending investigations and presenting conclusions during FDA, Health Canada, customer, or other regulatory inspections.
- Experience integrating manufacturing, laboratory, engineering, supplier, complaint, and quality-system data to identify broader systemic risks.
- Lean Six Sigma Green Belt or Black Belt certification.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality credential.
- Experience coaching investigators, conducting peer reviews, leading calibration sessions, or supporting investigator qualification programs.
Responsibilities
- Lead complex, high-risk, systemic, and cross-functional investigations from initiation through independent Quality approval, ensuring timely and comprehensive resolution.
- Develop investigation strategies, evidence plans, risk assessments, and decision frameworks to support root cause determination and product impact evaluation.
- Direct multidisciplinary teams in evidence collection, technical analysis, hypothesis testing, and scientific problem-solving.
- Evaluate quality, manufacturing, laboratory, supplier, engineering, and electronic system data to identify root causes, systemic vulnerabilities, and opportunities for preventive action.
- Facilitate senior-level discussions to align on investigation findings, risk assessments, product impact evaluations, and corrective action strategies.
- Author and present investigation reports, executive summaries, and technical conclusions during internal audits, customer audits, and regulatory inspections.
- Mentor and coach investigators, contribute to calibration activities, and support development of investigation capabilities across the organization.
Benefits
- Medical and dental coverage starting on day one for eligible roles.
- Basic life, accident, short-term and long-term disability, and business travel accident insurance.
- Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
- 401(k) Retirement Savings Plan with employee contribution options and company matching.
- Flexible Spending Accounts.
- Educational assistance programs.
- Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
- Family and medical leaves of absence and paid parental leave.
- Commuting benefits.
- Employee Discount Program.
- Employee Assistance Program (EAP).
- Childcare benefits.
- This position may be eligible for discretionary bonuses.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
