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Baxter Quality Assurance Supervisor – Line Ops (3rd shift) in Bloomington, Indiana

Quality Assurance Supervisor – Line Ops (3rd shift)

Req # JR - 027786

Location Bloomington, Indiana, United States

Job Category Quality Control

Date posted 09/29/2020

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Summary

The Quality Assurance Supervisor – Line Ops (QALO) is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to QALO and Manufacturing to ensure that finished products meet the required specifications by supervising QALO Associates I and II who provide quality oversight in the manufacturing areas. The QALO Supervisor provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Baxter Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The QALO Supervisor creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

  • Provides guidance, support, direction, and leadership through positive interactions with all personnel during daily operations

  • Plans and schedules the work of Quality Associates I and II

  • Interview, hire, train, and evaluate QALO personnel. Ensures all QALO oversight tasks are properly completed and documented

  • Reviews all risk assessment results and ensures compliance

  • Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety

  • Tracks and trends Quality data for review and reporting

  • Create and review Failure Investigation Reports for deviations and/or non-compliance issues that occur during production activities

  • Works closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP compliance

  • Manages change control activities/documentation such as validation change control documents, work orders, Hold requirements, etc

  • Develops and maintains documentation procedures, QA instructions and department policy procedures. Ensures product compliance regulations are followed.

  • Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations

  • Represent QALO during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs

  • Authors Nonconformance Reports and corrective and preventative action responses

  • Performs quality review of Nonconformance Reports, procedures, risk assessments/static pressure events, environmental chamber charts, MBR/MSS/LMR and SOP revisions, and validation documents as necessary

  • Provides technical support and guidance to Nonconformance Report authors

  • Leads cross functional continuous improvement project teams utilizing Lean principles

Job Requirements (Education and Experience)

  • Bachelor’s degree in a science discipline with 3 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor’s degree in non-science discipline with 6 years of Pharmaceutical Quality or Manufacturing experience

  • Knowledge of aseptic manufacturing processes preferred.

  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

  • Must wear appropriate PPE as required 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 sitting for long hours, but may involve walking or standing for periods of time.

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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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.

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