Manager I, Quality Control

Baxter • Hayward, CA

11h • $112,000 - $154,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. 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. This person serves as the site’s subject matter expert (SME) for the following quality control processes: QC Laboratory testing of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing. Involved with making critical decisions to release raw materials, in-process testing and final release of finished products in a timely manner. Identifies potential risks associated with laboratory operations and leads teams to resolve lab issues. Serve as a contact person for the Quality Laboratory and serves as the representative for the laboratory during all Quality and Regulatory Inspections.

Requirements

• Bachelor’s degree in Chemistry, Biological Science or related field.
• 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization or real-time stability testing
• 2+ years of supervisory experience.
• Strong understanding of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and/or real-time stability testing
• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability of managing complex projects and resolving complex lab Issues.
• Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
• Should have advanced knowledge in Statistical Analysis, QSMR, cGMP, CFR, USP GDP and ISO.
• Strong leadership, project and people management skills, and ability to make critical decisions.
• Strong understanding of business and/or industry.

Responsibilities

• Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing.
• Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSMR, cGMP, USP, and ISO rules, and guidelines), develop policies/procedures to implement these requirements for the laboratory operations.
• Ensure compliance with testing SOPs and specifications.
• Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
• Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
• Manage operating budget for the laboratory.
• Monitor the testing techniques & accuracy of all records & documentation that is done in the lab.
• Ensure completion of all testing, including special project/protocol testing in a timely & appropriate manner.
• Assure equipment maintenance & calibration, and internal audits are performed on schedule.
• Prepare, review & revise, as required, SOPs & specifications.
• Write memos, reports, protocols, & other appropriate documentation for proper functioning of the lab operation.
• Provide necessary 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 CAPA's.
• Support Laboratory investigations, Non-conformance/Exceptions and corrective/preventative actions and change controls as required
• Assure compliance with company procedures.
• Prepare the department ready for an audit by both internal and external authorities.
• Serve as the Quality Management for the lab. and interface with investigators during these inspections.
• Participates in management reviews of process performance, product quality advocating continual improvement within area of operations
• Ensure employees are properly trained and audited.
• Make appropriate staffing recommendations.
• Evaluate performance via performance appraisals and insure employees have development plans.
• Manage personnel functions including interviewing, hiring, performance appraisals, promotions, transfers & vacation schedules.
• Work with teams of business units and meet operational goals.
• Assure a safe and non-discriminatory working environment for employees.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees