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Quality Assurance Lead –Packaging (3rd shift)

Req # JR - 031060 Location Bloomington, Indiana Job Category Quality Control Date posted 12/01/2020

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Summary

The Quality Assurance Lead –Packaging is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to second and third shift Quality Assurance (QA) Associates and Packaging to ensure that finished products meet the required specifications by supervising Associates who provide quality oversight in the packaging areas. The QA Lead - Packaging 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 QA Lead - Packaging 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)

  • Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA and Baxter Quality systems is also required.
  • Must be a recognized by all levels of the facility as a subject matter expert in their area and be able to demonstrate leadership ability.
  • Plans and schedules the work of QA inspectors for required quality inspections and label printing and release.
  • Interviews, hires, coaches, and develops staff. Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
  • Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner.
  • Develops and maintains inspection and Label Control documentation procedures, QA inspection instructions and department policy procedures. Ensures product compliance regulations are followed.
  • Ensure business needs and timeliness requirements of the department are met or exceeded globally
  • Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Partners with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations.
  • Be involved in and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.
  • Assists and approves validations, audits and assessments. Authors, reviews, and/or approves NCRs, CAPAs, TSSs, Bills of Materials (BoMs), Finishing Specification Sheets (FSS), and Line Records.
  • Manages change control activities/documentation including validation change control, work orders, holds, etc.
  • Tracks and trends Quality data for review and reporting
  • Works closely with Production Supervision, Engineering, and Maintenance to ensure adequacy and appropriateness of resolutions to equipment issues that arise during product processing.

Job Requirements (Education and Experience)

  • Bachelor's degree in Engineering, Science or related field.
  • 3 years experience in Quality or cGMP Manufacturing / FDA regulated environment.
  • 1-2 years of experience in auditing techniques, interpreting regulations and quality system helpful.
  • Knowledge of inspection/labeling/packaging equipment and processes preferred
  • Good interpersonal/communication/influencing/negation skills.
  • Good project management skills
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
  • Strong technical, analytical and problem solving skills.
  • Good interpersonal, communication, influencing, negotiation skills.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:JDE, Trackwise, etc.)

Physical / Safety Requirements

  • Must wear appropriate PPE as required for various manufacturing 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.

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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 to [email protected] and let us know the nature of your request along with your contact information.

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