Manufacturing Technical RepresentativeReq # JR - 037298 Location Bloomington, Indiana, United States Job Category Technical Services Date posted 05/10/2021
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.
The Commercial Services Representative is a member of the core client team and interacts directly with clients. The Commercial Services Representative is responsible for multiple aspects of the project and provides exemplary customer service to both internal and external customers by focusing on performance and compliance. This position reports to the Sr. Manager, Commercial Services.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)
- Commercial contact for assigned clients externally and internally. Primary focus on low volume/small pharma partners.
- Manages client project updates and reviews with all levels of management.
- Participates (with assistance) in Business Review Meetings.
- Responsible for making and delivering accurate and timely quality decisions pertaining to client projects, questions, and requests.
- Escalates issues to impacted departmental manager and/or Director as necessary for corrective action implementation.
- Partners with manager and leadership staff to sign off on applicable documents, as the client representative in a timely manner.
- Partners with Program Management, Quality Assurance Associates, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information.
- Participates on client calls and on-site visits to discuss projects and issue resolutions.
- Participates (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME)
- Non-conformance report writing with assistance.
- Ability to provide expertise in aseptic processing.
- Capable of evaluating product impact and responsible for advising if product meets release criteria per regulatory constraints.
- Requires knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends.
- Understands the quality and technical requirements of each project.
- Maintains Project File, including recording and tracking interaction with client. Track, trend, compile and report client metrics as necessary.
- Performs Continued Process Verification per project to meet client and regulatory expectations.
- Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.
- Identifies and leads continuous improvement activities to maximize business results.
- Bachelor’s degree required, preferably in a science related field.
- Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
- Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization.
- Strong organizational skills (attention to detail) and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently.
- Ability to qualify for Grade A/B areas.
- Computer proficiency in Microsoft Word, Excel, Outlook and MiniTab and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
Physical / Safety Requirements
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position may require sitting or standing for long periods of 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.
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Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.