Novo Nordisk
Representative, Quality Assurance- 11am-2pm Mon thru Friday Shift
Novo Nordisk, Bloomington, Indiana, United States, 47401
Representative, Quality Assurance- 11am-2pm Mon thru Friday Shift
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position This role's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients. Relationships Reports to Supervisor. Essential Functions Supplier Management Collaborates with Quality Control, Materials Management, Supply Chain and Manufacturing to ensure that materials are available for use Provides support for the introduction of new material and service suppliers Support management and assessment of supplier change notifications and material change requirements Assists in the customer and supplier auditing process providing administrative support including information gathering and organization Provide quality support to Quality Control, Materials Management Center, and Supply Chain Review / Approve all incoming Material Specification Sheets Review / Release all inspected incoming materials Act as subject matter expert to internal and external customers regarding supplier qualification, material receipt / inspection / release and storage requirements Review and approve supply quality related records (e.g. deviations change controls, etc.) to ensure compliance to regulatory and procedural requirements is maintained Process supplier complaint investigation records and drive CAPA and disposition decisions Gather and report area metrics Perform supplier risk assessments Support maintenance of the approved supplier list Compile supplier pre audit data packages Support supplier performance monitoring program Provide quality oversight of receipt and storage of all bulk drug substance and cell banks Assess damaged materials / product within warehouse spaces Perform routine Gemba walks of warehouse spaces Perform system, cold storage equipment, and material holds as appropriate Other duties as assigned Quality Systems and Metrics Accountable for the Investigation and CAPA Management Systems Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal stakeholders to support the effective execution of the Investigation and CAPA systems Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations Files and maintains controlled documents Other duties as assigned Quality and Compliance Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions while onsite Review and approve responses to audit findings Assists in maintaining facility licenses and registrations Organizes documentation and facilitates review in support of client regulatory submissions Monitors and assesses changes to regulatory guidance and compendial monographs Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations Supports the management of customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR) Maintains statistical tools to meet requirements for system and process monitoring and review Maintains a sufficient understanding of the quality systems and operations File and maintain controlled documents Other duties as assigned On-Floor Support (DP and DS) Accountable for execution of the QA on the Floor program Partner with Manufacturing and other support teams Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing Review batch documents Review and disposition of media/buffer formulation batches Assist with revision of GMP documentation such as Standard Operating Procedures Initiate incident description forms and/or deviations as required when observed on the floor Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, formulation of media/buffer, and manufacture of bulk drug substance 70% of day is spent on the floor Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Provides QA support of Client Person in Plant (PIPs) Make solid quality decisions with limited oversight escalating all process-stopping issues to area management and quality management Acts as QA reviewer on Minor deviations Identify continuous improvement initiatives Participate in site and corporate quality and process improvement initiatives Represent perspective as necessary Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance Assists and train colleagues on aseptic behavior, techniques, and best practices Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position This role's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients. Relationships Reports to Supervisor. Essential Functions Supplier Management Collaborates with Quality Control, Materials Management, Supply Chain and Manufacturing to ensure that materials are available for use Provides support for the introduction of new material and service suppliers Support management and assessment of supplier change notifications and material change requirements Assists in the customer and supplier auditing process providing administrative support including information gathering and organization Provide quality support to Quality Control, Materials Management Center, and Supply Chain Review / Approve all incoming Material Specification Sheets Review / Release all inspected incoming materials Act as subject matter expert to internal and external customers regarding supplier qualification, material receipt / inspection / release and storage requirements Review and approve supply quality related records (e.g. deviations change controls, etc.) to ensure compliance to regulatory and procedural requirements is maintained Process supplier complaint investigation records and drive CAPA and disposition decisions Gather and report area metrics Perform supplier risk assessments Support maintenance of the approved supplier list Compile supplier pre audit data packages Support supplier performance monitoring program Provide quality oversight of receipt and storage of all bulk drug substance and cell banks Assess damaged materials / product within warehouse spaces Perform routine Gemba walks of warehouse spaces Perform system, cold storage equipment, and material holds as appropriate Other duties as assigned Quality Systems and Metrics Accountable for the Investigation and CAPA Management Systems Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal stakeholders to support the effective execution of the Investigation and CAPA systems Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations Files and maintains controlled documents Other duties as assigned Quality and Compliance Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions while onsite Review and approve responses to audit findings Assists in maintaining facility licenses and registrations Organizes documentation and facilitates review in support of client regulatory submissions Monitors and assesses changes to regulatory guidance and compendial monographs Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations Supports the management of customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR) Maintains statistical tools to meet requirements for system and process monitoring and review Maintains a sufficient understanding of the quality systems and operations File and maintain controlled documents Other duties as assigned On-Floor Support (DP and DS) Accountable for execution of the QA on the Floor program Partner with Manufacturing and other support teams Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing Review batch documents Review and disposition of media/buffer formulation batches Assist with revision of GMP documentation such as Standard Operating Procedures Initiate incident description forms and/or deviations as required when observed on the floor Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, formulation of media/buffer, and manufacture of bulk drug substance 70% of day is spent on the floor Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Provides QA support of Client Person in Plant (PIPs) Make solid quality decisions with limited oversight escalating all process-stopping issues to area management and quality management Acts as QA reviewer on Minor deviations Identify continuous improvement initiatives Participate in site and corporate quality and process improvement initiatives Represent perspective as necessary Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance Assists and train colleagues on aseptic behavior, techniques, and best practices Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite