Investigations Project Leader

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.


Summary(Main purpose of the job)

The Investigations Project Leader position is responsible for implementing and supervising all deviation investigation activities for the area (ERs, OOLs, OOSs, OORs, and OOTs). Develop and track effective Corrective Actions (CAs). Implement and maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply. Design and oversee rapid investigation processes for the Bulk/Filling areas that lead to true root cause identification and implement effective corrective actions that eliminate potential for repeat deviations. Essential Duties and Responsibilities(List of Primary responsibilities of this role that account for 5% or more of the work. Incumbent may perform other duties as assigned.)

1) Position is expected to provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.

2) Responsible for supervising the day-to-day deviation resolution efforts.

3) Review, approve, and manage documentation changes for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.

4) Emphasize and improve as needed training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.

5) Develop and implement performance measurement and internal auditing programs in order to routinely evaluate deviation response and occurrence rates. Liaison with Quality and Regulatory Compliance during compliance walks. Implement changes as needed based on assessments.

6) Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.

7) Provide a positive and equitable working environment emphasizing the Baxter Shared Values: Respect /Responsiveness / Results.

8) Identify, lead, and implement process improvements and Value Improvement Projects to drive success in the areas of compliance, throughput, work place safety, cost effectiveness, and product lead time.


Qualifications


Qualifications(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.)

Demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels and lead effectively and efficiently in a team environment.
In-depth process knowledge of related manufacturing equipment and processes. Ability to analyze and interpret scientific and statistical data. Strong professional writing skills and verbal skills. Ability to prepare and present technical reports and trends to senior management. Experienced understanding of cGMPs and other regulatory guidelines applicable to the edical/pharmaceutical industry. Strong assessment and troubleshooting skills. Ability to respond to detailed inquiries, and present information to groups and senior management. Good computer skills and working experience with Microsoft Office applications.

Education and/or experience
Bachelor's degree or equivalent experience. In addition a minimum of 6 - 8 years product development or manufacturing experience required and three years project management experience.

Physical Demands
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. Must be able to aseptically gown and work in aseptic environments. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment. May be required to work or be assigned to a different shift as needed. Clean Room and cool/hot storage conditions. 5% travel.

As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V