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Summary:
Provide support for the daily operations and control of work flow of a Final Product Microbiology Testing Lab. Implement microbiological testing standards and monitor adherence to regulatory guidelines. Accountable for all safety measures of lab and completion of Safety corrective actions. Mentor and develop lab associates while inducing a healthy working environment.
Responsibilities:
- Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.
- 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. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
- Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
- Maintain expenses at or below budget for the lab.
- Assure a safe and non-discriminatory working environment for employees.
- Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans.
- Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
- Assure equipment maintenance and calibration, and internal audits are performed on schedule.
Qualifications:
- Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical manufacturing labs.
- Experience in aseptic processing of drug solutions.
- Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.
- Strong knowledge of final product sterility testing, bacterial endotoxin testing, and environmental monitoring.
- Working knowledge of statistical tools used for data reporting and trending.
Education:
Bachelor’s Degree in microbiology, or biological science with Microbiology Laboratory coursework. 5-7 years’ experience in pharmaceutical industry.
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
Reasonable Accommodations
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.
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