Product Quality Assurance Specialist

2 months ago

Massachusetts, United States Novo Nordisk Full time

About the Department

The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our focus on innovation ensures we're constantly building future capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, and we reward hard work and dedication with opportunities for continuous learning and personal development. Are you ready to maximize your potential with us?

The Position

The Product QA Specialist will be responsible for the review and approval of GMP clinical pharmaceutical batch production records while maintaining relationships with external manufacturers to drive continuous improvement to their related quality systems and processes. This individual may also serve as a subject matter expert and trainer in batch record review as well as assist in coordination and communication of daily activities within CMC Quality Assurance.

Relationships

Reports to Manager, Quality Assurance Batch Release.

Essential Functions

Receipt and internal tracking of batch documentation from external partners and the securing and archiving of these records within Novo Nordisk systemsReview and approve contractor's manufacturing, packaging, and analytical records for data integrity and GMP compliance and consistency with company policies and procedures necessary for Quality disposition of clinical intermediates, API and finished drug products at Novo NordiskProvide QA support for the review of external partner deviation investigations/change controls and initiate necessary records according to company proceduresCollect and maintain monthly product quality metrics data for QA ManagementMaintain systems used for tracking various GMP manufacturing associated support activitiesGeneration and/or revision of GMP documentation such as standard operating procedures and related formsWorks closely with Technical Operations, Quality Control, Regulatory, Supply Chain, and external partners to prioritize documentation review and product releaseContinually monitor quality systems and procedures for improvement opportunities while ensuring compliance to applicable regulatory requirements and standardsMaintain documentation and records to ensure GMP Quality standards and complianceSupport Regulatory Authority inspections, and internal & external audits as neededOther duties as assigned Physical Requirements 0-10% overnight travel required. QualificationsBachelor's degree in a scientific or life science field5+ years of related GxP (GMP, GCP, GLP) industry experience (or 3+ years with advanced degree)3+ years direct experience in a GMP Quality Assurance roleExperience with the application of cGMPs, FDA and ICH guidelines, EU regulations, and other standards in the pharmaceutical industryGeneral knowledge in cGMP manufacturing & production processes with oligonucleotides preferredExperience in a virtual, contract manufacturing based GMP environment for chemical or biologics based drug substances, drug products and final dosage forms (injectables) preferredExperience with Veeva Vault or similar electronic document management system preferredStrong attention to details, organizational skills, ability to multitask in a dynamic, fast-paced environment, and the ability to adapt to changing prioritiesDemonstrated analytical and logic skills with a focus on fact-based decision making and problem-solvingExcellent assertive written/verbal communications skills, including the ability to express ideas and knowledge effectively requiredExcellent stakeholder management, collaboration and conflict resolutions skillsAbility to identify, elevate issues, identify solutions, and make decisions under time pressureExposure to regulatory inspection is preferred The base compensation range for this position is $80,670 to $141,170. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on 7/19/2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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