Quality Supervisor
Bloomington, IN
Req ID 51074BR
Business Title
Quality Supervisor
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Indiana
Location of Position
Bloomington, IN
Shift_
3rd
Job Description
Summary :
The QA Finishing Line Ops Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Quality Finishing Operations Manager. He or she provides direct support to Quality Line Operations and Label Control to ensure that labeling materials, process materials, packaging and finished products meet required standards. This involves supervising QA inspectors who perform label issuance and inspection activities throughout inspection, labeling, and packaging. The QA Finishing Line Ops Supervisor provides decision making and oversight to ensure compliance to all standard operating procedures and Finishing Specification Sheets. He or she must fully support and drive quality operations on the production floor and communicate effectively with production team members, multiple levels of management, and other customer support departments. The QA Finishing Line Ops Supervisor c reates 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 QA inspectors for required quality inspections and label printing and release.
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Ensures that all inspection and material releases are properly completed and documented in support of batch release time goals and customer expectations.
• Reviews all quality assessment results and ensure compliance
• 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.
• Performs and documents Failure Investigation Reports for deviations and or non-compliance issues that occur during production activities
• Develops and maintains inspection and Label Control documentation procedures, QA inspection instructions and department policy procedures. Ensures product compliance regulations are followed.
• Manages change control activities/documentation including validation change control documents, work orders, Hold requirements, etc.
• Leads teams in continuous improvement project activities
• Represents Finishing Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.
• Reviews and provides Quality Approval for Finishing Specification Sheets / Line Records / SOPs
• Reviews and approves Bill of Material in the ERP system
Job Requirements
Job Requirements (Education, Experience and Qualifications ):
• Bachelor's degree required, preferably in a Science related field
• Minimum 3 years experience in Quality or equivalent pharmaceutical industry experience required.
• Knowledge of inspection/labeling/packaging equipment and 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 personal protective equipment as applicable.
• 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.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
