Location
Type
Status
Open
Bloomington, IN
Full-time
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.
Full-time
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.
Bloomington, IN
Full-time
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.
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