Quality Associate II (Audit)

About the Role

This is where your creativity addresses challenges. You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

About the Team

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

Responsibilities

• Maintains Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
• Manages the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for audits performed.
• Prepares for and conducts internal and supplier audits by researching background information and developing assessment strategy; collects and analyzes objective evidence regarding issues and risks.
• Reports audit/inspection findings to management and evaluates audit responses, CAPA plans, and CAPA objective evidence for adequacy, including root cause determination and timeliness; escalates issues to management as appropriate.
• Manages audit files through the process to closure and performs follow-up audits to confirm CAPA effectiveness.
• Coordinates and manages state licensing program.
• Leads regulatory intelligence activities including analysis and distribution of FDA guidance, warning letters, consent decrees, and industry publications to relevant stakeholders.
• Supports external regulatory inspections including back room management, document retrieval, and commitment tracking through closure. May serve as front room host/table lead.
• Prepares management reports depicting compliance trends for Management Review purposes.
• Mentors and trains Quality Compliance Associates I and Technicians on audit methodology and compliance procedures.
• Participates in continuous improvement initiatives and quality system enhancement projects.
• Supports customer compliance activities including customer audits and customer regulatory information requests.

Requirements

• Candidate must not be allergic to Penicillins or Cephalosporins.
• BS in business or science or equivalent degree.
• Minimum 3 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
• Minimum 3 years of related quality auditing experience in cGMP environments; previous internal or external auditing experience required.
• ASQ CQA and/or other auditor accreditation strongly preferred.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral – with ability to present to management.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations and regulatory inspection processes.
• Strong organizational skills with ability to lead multiple complex projects.
• Proficiency in quality software systems (e.g., TrackWise) and MS Office applications.
• Resourceful, self-reliant, self-motivated, and confident.
• General knowledge of Lean Six Sigma and other continuous improvement tools preferred.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Pay

The estimated base salary for this position is $88,000 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with options for employee contributions 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.