Your role at BaxterThe Quality Associate III (Quality Engineer) is a key individual contributor responsible for driving quality engineering initiatives and supporting regulatory compliance within a pharmaceutical manufacturing environment. This role leads validation efforts and quality improvement projects, with a strong focus on enhancing and modernizing visual inspection programs for sterile products. The position partners cross-functionally to implement process improvements and ensure compliance to quality standards. This role plays a critical part in advancing product quality and supporting key regulatory and operational priorities.
What you'll be doing- Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
- Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor.
- Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- Manage activities in achieving defined quality goals in an efficient, accurate and timely manner.
- Ensure business needs and timeliness requirements of the department are met or exceeded.
- Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
- Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.
- Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area.
- Assists and writes validations, audits and assessments.
What you'll bring- Bachelor's degree in Science or Engineering required
- 5 or more years experience in IT, Engineering, Science or related field..
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
- Strong technical, analytical and problem solving skills.
- Good interpersonal, communication, influencing, negotiation skills.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Good interpersonal/communication/influencing/negation skills.
- Good project management skills
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
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US Benefits at Baxter (except for Puerto Rico)This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
