Supv, Quality Lab

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.
1) Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.


2) Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.


3) Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.


4) Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.


5) Maintain expenses at or below budget for the lab.


6) Assure a safe and non-discriminatory working environment for employees.


7) Ensure employees are properly trained and audited.


8) Make appropriate staffing recommendations.


9) Evaluate performance via performance appraisals and insure employees have development plans.


10) Prepare, review and revise, as required, SOPs and specifications.


11) Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.


12) Assure equipment maintenance and calibration, and internal audits are performed on schedule.


Qualifications
1) Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs.


2) Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.


3) Bachelors Degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework. 5-7 years experience in healthcare industry.


4) Must have experience with Method Validation and Method Transfer.


5) Heavy HPLC work a plus.



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