Req #: 1800019H_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/10/2018 11:41:58 AM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Supervise, plan, organize, direct and evaluate the activities of the Quality Laboratory Instrumentation and Validation groups. Responsible for controlling the flow of work in this group. Lead project teams in troubleshooting and problems solving activities. Prepare statistical and quality reports on the assay results, if necessary. Implement testing standards and policies, and ensure quality and regulatory compliance. Supervise safety. Evaluate and enhance performance of quality laboratory personnel.
Essential Duties & Responsibilities
- Develop proposals and execute validations for manufacturing processes and laboratory systems. Insure completion of all protocols and validations in a timely and appropriate manner. Report progress of protocol and validation work and significance of results. Recommend utilization of the results or changes in the scope of work or termination of projects.
- Prepare and evaluate data trends, and provide an expert advice to teams involving in the troubleshooting and problem solving activities.
- 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.
- Assure compliance with company procedures, quality and regulatory requirements, and guidance including GLP, QSR, cGMP, USP, and CDR rules, regulations, and guidelines. Prepare the department ready for an audit by Quality Assessment, Corporate, or the FDA. Serve as a technical expert and interface with investigators during both internal and external inspections.
- Evaluate the State of Art technology, determine its applicability to business units, and implement new testing methods.
- Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the department.
- Recommend instrumentation purchases and upgrades for the laboratory that ensures optimum lab performance. Manage the laboratory equipment maintenance and calibration program. Troubleshoot and resolve instrument problems. Attend seminars to stay current in the field of lab instruments and methods.
- Provide support to other Baxter plants related to troubleshooting lab equipment and processes, development of SOPs and assuring compliance with regulatory requirements.
- Sustain a clean and safe work area using 6S principles
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Qualifications for this role
- Must know operating and troubleshooting procedures for lab equipment and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
- Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.
- Should have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Project Management Skills are plus.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
Education & Experience
Bachelors Degree in Chemistry, or biological science with 9-13 years experience, or Masters Degree in Chemistry, or biological science with 7-11 years experience, PhD in relevant scientific field with 4-8 years experience
A Career that Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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.
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.