at Baxter Healthcare Corporation in Round Lake, Illinois, United States
Job Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
What you will do
Provide quality support activities within Research and Development to ensure that the organization adopts a total quality methodology in their day-to-day operations. Communicate and model the quality philosophy to the departments. Identify and lead continuous improvement initiatives for quality processes and systems that have impact across the R&D business segments.
Develop, implement and maintain quality assurance operations relating to Quality Management System in an R&D environment and manages compliance.
Provide support in preparing for regulatory inspections through focused system audits, mock inspections, and training/guidance in managing regulatory inspections.
Provide quality support by actively participating on development teams to provide input on defining requirements, interpreting internal/external regulations & requirements, and identifying regulatory/quality risks.
Review and approve quality related documents, including but not limited to standard operating procedures, change controls, protocols/reports, chamber qualifications /requalification's, equipment out of tolerance notifications, computerized system validation documentation and Laboratory Investigation Reports for compliance to regulations and Baxter requirements.
Lead or participate in local R&D internal system audits.
Provide Nonconformance / CAPA support.
Perform as the Location of Use (LOU) role and primary point of contact for owning, editing and approving SCAR records and obtaining supplier responses to the corrective actions; as primary RAM Action record (assessment) owner, as applicable
Maintain expertise in areas of responsibility through ongoing training and participation in industry associations.
What you will bring:
Thorough knowledge of Drug/Device/Biologics GMP's, GLP's and ISO standards required.
Familiar with Computerized System Validation and Electronic Record Electronic Signature Requirements (21 CFR Part 11).
Ability to develop, approve, and implement standard operating procedures, training programs, and internal audit plans.
Must have excellent written and oral communication skills, negotiation skills, ability to manage multiple projects, and excellent interpersonal skills.
Demonstrated success working with multifunctional, global teams within and external to Baxter.
Strong project management and presentation skills.
Strong technical, analytical judgment and problem-solving skills.
Ability to respond to customers in a timely manner.
Bachelor's degree in a scientific or engineering discipline, master's degree a plus.
Auditing skills with 2-3 years' experience in auditing techniques.
Minimum of 5-8 years of experience in Quality, or related field in a pharmaceutical/medical device company.
Membership in the American Society of Quality desired along with ASQ CQA, CQE or CQM certification
Knowledgeable in 21 CFR Parts 11 & 58, ISO 13485, ISO 10993, ISO 9000
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $80,000 to $180,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious... For full info follow application link.
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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