Representative, Quality Assurance- 11am-7:30pm Mon thru Friday Shift

New Today

About the Department
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
Provide immediate feedback during routine observation to line leaders and colleagues, both positive practices and opportunities for improvement to allow for further development of colleague capabilities
Observe, coach and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impact processing
Analyze, develop, and improve quality systems and associated business processes to achieve compliance with global regulatory requirements
Perform investigations using root cause analysis tools and work with impacted areas on CAPAs to address root cause
Support investigation activities utilizing root-cause and problem-solving methodologies, including support of CAPA development and implementation
Develop and maintain department and site metrics for monitoring critical process and Quality attributes
Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects
Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment
Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner
Follow all SOPs, cGMPs, batch records, and remain current with all training requirements
Other duties as assigned
Product Quality
Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports
Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations
Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships
Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements
Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems
Supports execution of QA on the Floor program
Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Other duties as assigned
Batch Review/Disposition (DP and DS)
Reviews executed batch records
Dispositions product with delegation
Ensures all in-process specifications are met
Ensures all corrections found are made to batch records
Interacts with clients in a professional manner to ensure timely resolution of post-disposition corrections
Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
Maintain a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Other duties as assigned.
Physical Requirements
100% onsite at the Bloomington, Indiana site.
Qualifications
Bachelor's degree and 2+ years of experience or Master's degree and 0+ years of experience required
Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred
A strong working knowledge of quality systems and processes, preferred
GxP experience or other regulated industry, required
Technical Requirements
Ability to use Excel, Word, and other office systems required
Ability to learn and use quality management software such as TrackWise® or ComplianceWire® required
Ability to understand and independently apply CGMPs to everyday work required
Intermediate understanding of pharmaceutical laboratory and/or production operations required
Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor required?
Ability to problem solve and execute and monitor corrective actions required
Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions required
Must be able to read and understand English-written job instructions and safety requirements required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Location:
Bloomington

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