Laboratory Manager

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Laboratory Manager, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

Direct and prioritize the operations of Chemical and Microbiology, external laboratory supplier Laboratories. This includes the participation in the development of Aibonito policy systems and standard operating procedures for specifications, and directions for testing in the following areas: Raw Materials, In- Process Materials, Finished Products, Stability Program, Method Transfer.

Responsible for compliance within assigned areas to all government regulations, company policies and procedures. Responsible for the validation activities throughout the department, including change control and Quality Monitoring.

The primary end result of this position is to assure all activities carried out through the site are accurately completed in accordance with FDA guidelines and that laboratory testing services and Receiving and Inspection Activities are carried out in an expeditious and cost-effective manner maintaining a high degree of compliance to FDA regulations and meeting the overall business priorities and schedules.

Coordinate all lab activities with Materials and Manufacturing Management; own the activities of the Chemical Laboratory and R&I Operation group. Responsible for the supervision and training of exempt and non-exempt personnel in the group.

The Manager either independently or in association with supervised employees is responsible for the validation of all Laboratory processes assuring it is done in full compliance to FDA guidelines.

Establish, implement and lead all laboratory standard operating procedures and policies.

Lead the analytical method transfer program for the laboratory. Active participation in process validation and revalidation programs. Responsible for the analysis of validation samples.

Identify and implement with the help of R&D (if needed) the improvements in laboratory testing methods and automation to upgrade the laboratory efficiency, consistent with the lowest possible cost objectives of the business.

Participate in the approval, revision, and implementation of all raw material, in-process, finished product, stability specifications, and other documents.

The Manager either independently or in association with supervised employees is responsible for the change control system approvals and evaluation.

The Manager either independently or in association with supervised employees is responsible for the Quality Monitoring program for the departments.

SUPERVISORY RESPONSIBILITIES

Leads subordinates who supervises employees in the Chemical, Microbiology Labs and Receiving and Inspection Area. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, development and training employees; planning, assigning, and directing work; appraising performance; rewarding and focusing employees; addressing complaints and resolving problems.

What you'll bring

• A minimum of a bachelor's degree in Microbiology, Chemistry or Science: Extensive, minimum seven years, pharmaceutical experience with at least one year of quality control (laboratory operation) supervisory/management experience.
• Good interpersonal and troubleshooting skills
• Critical Thinking and analytical skills
• Fully bilingual, (English and Spanish)