Quality Associate II (Weekend night shift, 7PM-7AM)

Location: NORMAN, IN (47264)
Company: Baxter
Industry: IT
Job Type: Full Time
Posted: 5 days ago

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.

Summary

The Quality Associate II Line Operations is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Supervisor. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during the manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter Standard Operating Procedures. They facilitate training of new Quality Associates in QALO. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities

  • Facilitates training qualifications and on-going support for associates, including activities such as aseptic intervention oversight, room inspections, oversight checklists, and equipment chart review
  • Leads cross functional continuous improvement project teams applying Lean principles
  • Serves as principal Quality author for Significant Nonconformance (potential batch impact) Reports
  • Provides technical support and guidance to nonconformance authors
  • Acts as team leader to shift associates in absence of supervisor
  • Assists supervisor in maintenance of visual controls and accountability tools
  • Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
  • Reviews records to ensure they are complete, accurate and follows current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
  • Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
  • Performs Quality functions in classified areas, including checklists, and aseptic intervention oversight.
  • Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations.
  • Authors Nonconformance Reports, Risk Assessments, and corrective action responses for exception variances.
  • Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
  • Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

Job Requirements (Education, Experience and Qualifications):

  • Bachelor's degree (preferred science field) and two years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
  • Proven understanding of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Maximo, Trackwise, etc.)

Physical/Safety Requirements:

Must wear appropriate PPE as the need arises for various manufacturing areas

Must be able to gown qualify for Grade A/B areas.

Duties may require overtime work, including nights and weekends

Use of hands and fingers to manipulate office equipment is required

Position requires standing for long hours, but may require sitting for periods of time

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 beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .

076039

Web Reference : AJF/418469259-202
Posted Date : Mon, 19 Sep 2022

Please note, to apply for this position you will complete an application form on another website provided by or on behalf of Baxter. Any external website and application process is not under the control or responsibility of IT JobServe

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