Quality Engineer Associate III

Baxter•Round Lake, IL

14h•Onsite

About The Position

The 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.

Requirements

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
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.

Responsibilities

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.

Benefits

medical and dental coverage that start 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
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits