Manager I, Quality Control

Your Role Responsible for supervising, planning, organizing, directing and evaluating all activities of the Quality Laboratory to ensure the safety and reliability of Baxter products, and compliance with quality and regulatory requirements. The person serves as the site’s subject‑matter expert for QC laboratory testing of chemistry, environmental monitoring, microbiology, sterilization and real‑time stability testing. Involved with making critical decisions to release raw materials, in‑process testing and finished products in a timely manner. Identifies potential risks associated with laboratory operations and leads teams to resolve lab issues. Serves as the contact person for the laboratory and representative during all quality and regulatory inspections. What You’ll Be Doing Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiology, sterilization and real‑time stability testing. Interpret applicable quality and regulatory requirements (FDA, GLP, QSMR, cGMP, USP, ISO) and develop policies/procedures to implement these requirements for laboratory operations. Ensure compliance with testing SOPs and specifications and monitor testing techniques and accuracy of all records and documentation. Work closely with manufacturing and product development teams and participate in proactive functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support. Manage operating budget for the laboratory. Ensure completion of all testing, including special project/protocol testing, in a timely and appropriate manner. Assure equipment maintenance & calibration, and internal audits are performed on schedule. Prepare, review and revise SOPs & specifications; write memos, reports, protocols and other documentation for proper functioning of the lab operation. Provide support related to non‑conformity reports, validations, change controls, out‑of‑specifications, out‑of‑trends, laboratory error reports, risk assessments, impact assessments, market complaints and relevant CAPAs. Support laboratory investigations, non‑conformance/exception and corrective/preventative actions and change controls as required. Assure compliance with company procedures; prepare the department for an audit by both internal and external authorities; serve as the Quality Management for the lab. Participate in management reviews of process performance, product quality, advocating continual improvement within the area of operations. Ensure employees are properly trained and audited; make appropriate staffing recommendations; evaluate performance via performance appraisals; insure employees have development plans. Manage personnel functions including interviewing, hiring, performance appraisals, promotions, transfers and vacation schedules. Work with business unit teams and meet operational goals. Assure a safe and non‑discriminatory working environment for employees. What You’ll Bring Bachelor’s degree in Chemistry, Biological Science or related field. 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiology, sterilization or real‑time stability testing. 2+ years of supervisory experience and strong understanding of chemistry, environmental monitoring, microbiology, sterilization and/or real‑time stability testing. Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs. Ability to manage complex projects and resolve complex lab issues. Excellent supervisory and interpersonal skills, and ability to communicate with all levels of personnel and regulatory authorities. Advanced knowledge in statistical analysis, QSMR, cGMP, CFR, USP GDP and ISO. Strong leadership, project and people management skills; ability to make critical decisions; strong understanding of business and/or industry. Compensation Estimated base salary for this position is $112,000 - $154,000 annually. Individual pay is based on location, skills, expertise, experience and other factors and may be higher or lower than the range. The position may also be eligible for discretionary bonuses. Applicants Must Be Authorized to Work Applicants must be authorized to work for any employer in the U.S.; we are unable to sponsor or take over sponsorship of an employment visa at this time. 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. #J-18808-Ljbffr Baxter International Inc.