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Summary

Manage and coordinate special projects, protocols, and process improvement efforts for the facility’s Quality Control Laboratories.  Assesses and identifies regulatory and quality risks in microbiological activities and processes; conducts gap analyses, implements Quality System policies and procedures, and manages compliance in areas of responsibility. Leads multiple process/product improvement projects. Demonstrates effectiveness in decision-making, problem solving, project management, and team leadership.

Essential Duties and Responsibilities. 

• Contribute to the design and implementation of robust, risk-based environmental monitoring programs for facility cleanroom complexes used in the manufacture of aseptically-filled SVP and LVP dosage forms
• Utilize quality risk management tools to develop microbiological risk assessments for existing and prospective manufacturing equipment and processes and evaluate overall facility microbial contamination control strategies
• Serve as a microbiology SME during routine audits by global regulatory agencies, pharma manufacturing partners and internal corporate auditors; defend microbiology laboratory practices and aseptic manufacturing processes and contribute written responses to audit observations
• Develop, write, review and execute microbiological method validation and suitability analysis protocols with minimal guidance; manage multiple projects and validations concurrently
• Participate on a cross-functional late-stage product development and commercialization team as a facility microbiology and sterility assurance SME
• Design, author and execute formal lab-scale experimental microbiological characterization studies and generate microbiological risk assessments in support of NDA/ANDA regulatory submissions for new products
• Perform exhaustive root cause investigation into microbiological and manufacturing process nonconformances and lead CAPA team efforts to develop and implement effective corrective actions and process improvements
• Actively contribute and execute strategies within the QC Microbiology Laboratory and Quality Operations organization to maintain regulatory compliance, improve methods and technologies and increase cost effectiveness using six sigma and LEAN manufacturing principles

Qualifications. 

• Strong knowledge of the FDA Quality System and Regulatory Reporting regulations related to microbiology quality control, and USP Guidelines
• Ability to perform all duties required of previous levels
• Strong interpersonal skills
• Readily accepting of assignments to new/different products
• Ability to prioritize multiple tasks
• Ability to lead people and encourage teamwork
• Customer focus
• Ability to drive decisions quickly and effectively
• Proficiency with computer-based systems and software such as Microsoft Access, Excel, Word, PowerPoint, TrackWise, TcU, GME, and Adobe Acrobat.
• Excellent written/verbal communication and organizational skills
• Ability to effectively communicate across multiple levels within the organization
• Ability to make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills
• Must not be allergic to Penicillin or Cephalosporins.
• Detail oriented

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• Bachelor’s degree in Microbiology. Master’s degrees in microbiology preferred
• 5-8 years relevant work experience in cGMP related industry and/or Pharmaceutical Microbiologically.
• Experience with driving process improvement initiatives and projects preferred
• Application of lean principles preferred

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.
                                                                                                                                                               
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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.