Quality Associate II
Bloomington, IN
Req ID 51492BR
Business Title
Quality Associate II
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Indiana
Location of Position
Bloomington, IN
Shift_
1st
Job Description
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 (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
•Facilitates training qualifications and on-going support for associates, including activities such as aseptic intervention oversight, room inspections, line clearances, oversight checklists, logbook review, work order review, and equipment chart review
•Leads cross functional continuous improvement project teams utilizing Lean principles
•Serves as principal Quality author for Level II (potential batch impact) Exception Reports
•Provides technical support and guidance to Level I EX 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 compliant with 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, aseptic intervention oversight, and line clearances.
•Reviews completed terminal sterilizer and autoclave charts as well as filter integrity testing results
•Provides Quality verification of batch related labels and samples.
•Confirms various investigation reports and provides review of completed work orders and proposed standard operating procedure revisions.
•Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations.
•Authors Exception Reports, Risk Assessments, and corrective action responses for exception variances.
•Conducts monthly/quarterly quality assurance audits for critical logbooks and bi-annual inspections of classified areas.
•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
Job Requirements (Education, Experience and Qualifications):
•Bachelor's degree in a science discipline (preferably Chemistry or Microbiology with 2 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor's degree in non-science discipline with 5 years of Pharmaceutical Quality or Manufacturing experience
•Working knowledge 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, 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.
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.
