This section focuses on the main purpose of the job in one to four sentences.
Successfully perform all the primary activities as defined in the QAI and QA II job positions. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that account for the majority of the work. The incumbent will perform other duties assigned.
- Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
- Manage activities of self 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 globally
- Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Partners with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
- Be involved in and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- 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.
- Must be a recognized by all levels of the facility as a subject matter expert in their area and be able to demonstrate leadership ability.
- Assists and writes validations, audits and assessments.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- 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
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Education and/or Experience:
Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree in Science or Engineering required
- 5-8 years experience in IT, Engineering or related field.
- 2-3 years of experience in auditing techniques, interpreting regulations and quality system helpful.
- 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.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.