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Senior Quality Assurance Area Specialist I – QA, IT & Automation
Novo Nordisk. Responsible for production activities and validation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in cGMP manufacturing, quality management systems, and validation processes within the pharmaceutical industry. Capable of effectively communicating quality requirements and collaborating with cross-functional teams to ensure compliance and resolve quality-related issues.
Highest-signal resume keywords
Bachelor's Degree In Life SciencesMinimum Five Years Experience In Pharmaceutical IndustryStrong Knowledge Of cGMPs And ValidationQuality Management Systems ExpertiseStrong Written And Verbal Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CGMP ManufacturingBatch Review ProcessesQuality Management SystemsValidation ProcessesQuality OversightChange Control RequestsRoot-Cause AnalysisProcess ConfirmationsDocumentation ReviewSpot Checks
Soft Skills
Ability To Work IndependentlyCooperative Stakeholder EngagementPlanning And Organizing TasksInnovative PrioritizationAssisting Others In Development
Tools & Technologies
LIMsSAPNovoGlowMS OfficePowerPointWordExcel
Industry Keywords
Pharmaceutical IndustryComplianceISO StandardsCorporate SOPsQuality Assurance
About the role
Key responsibilities & impact- Responsible for production activities and validation
- Ensure relevant compliance issues are addressed and handled in close collaboration with production
- Review batch reports and release API materials
- Support validation projects by communicating Novo Nordisk project quality requirements
- Assess suppliers' ability to support test and qualification activities
- Support projects in resolving quality-related issues and communicate decisions clearly
- Perform spot checks of validation documentation
- Review and approve API/intermediate batch documentation in systems such as LIMs, SAP, and NovoGlow
- Ensure site compliance with regulations, ISO standards, and corporate/local SOPs
- Review and approve change control requests and deviations
- Provide guidance to departments regarding quality-related activities
- Participate in root-cause analysis
- Participate in process confirmations and quality oversight
- Serve as an authorized person according to the Novo Nordisk Quality Manual
- Report to the Manager, Quality Assurance
- Perform other assigned accountabilities
Requirements
What you’ll need- Bachelor's Degree in Life Sciences, Engineering, or related field required
- Minimum of five (5) years of experience within the pharmaceutical industry required
- Good knowledge of cGMP manufacturing and production processes and how to apply it
- Good knowledge of batch review processes
- Good knowledge of quality management systems
- Good knowledge of quality oversight and on-floor production support
- Strong knowledge of cGMPs and validation
- Strong knowledge of Quality Management Systems
- Ability to perform tasks independently, accurately, and within defined time frames
- Ability to work with customers/stakeholders in a cooperative manner
- Strong written and verbal communication skills
- Strong computer skills in MS Office, PowerPoint, Word, Excel, etc.
- Proven expertise in planning and organizing tasks preferred
- Willingness to assist others in developing plans in a cross-functional environment preferred
- Innovative approach to establishing priorities preferred
- May move equipment and/or supplies weighing up to 33 pounds
- May be required to stand for up to a 12-hour shift
- May require corrected vision to 20/20 or 20/25, color vision, and ability to work in loud-noise environments with hearing protection
Benefits
Comp & perks- Leading pay and annual performance bonus for all positions
- 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
- 14 weeks paid parental leave
- 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Opportunities, resources, and mentorship for career growth