Quality Assurance Area Specialist IV-Bloomington (Multiple Openings)

Novo Nordisk • Bloomington, IN

395d

About The Position

The Quality Assurance Area Specialist IV role at Novo Nordisk in Bloomington, IN, is focused on ensuring compliance with quality processes and regulations within the Fill & Finish Expansions (FFEx) department. This position involves overseeing batch release authority, serving as a subject matter expert in quality assurance processes, and leading improvement activities to enhance operational efficiency. The role requires collaboration across multiple sites and cultures, emphasizing the importance of quality in aseptic production and the development of new filling capacities.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required.
• Minimum of ten (10) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems required, preferably in the pharmaceutical or medical device field.
• Demonstrated expertise in Regulations & quality systems (e.g., product disposition, Deviations/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.) required.
• Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred.
• Experience with Risk Assessment & Vendor Assessments required.
• Expert in current good manufacturing practice (cGMP) documentation practices.
• Excellent troubleshooting skills: able to identify root cause of problem required.
• Demonstrated knowledge of critical controls & input/output requirements for processes in one or more of the following areas: product disposition, DV/CAPA, Change Control, semi-finished manufacturing, finished manufacturing, QC, Microbiology/ Environmental Monitoring (EM), IT & process utilities preferred.
• Excellent written & verbal communication skills required.
• Auditing experience with certification preferred (internal/external) required.
• Experience with LEAN, Six Sigma & other continuous improvement methodologies required.
• Expert competence in multiple core validation areas (sterilization, packaging, cleaning, utilities, laboratory methods or equipment, process, or computer system and/or equipment validation) preferred.
• Experience with statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required.
• Expert in utilizing appropriate root-cause analysis tools & techniques preferred.
• Expert in Risk Assessment & Risk Management required.

Nice To Haves

• Knowledgeable in PLC, SCADA, Virtualization/Storage, Active Directory, MES/LMES (Oracle) and/or MS SQL.
• Knowledge of SAP, PAS-X, and BMS preferred.
• IT audit experience desirable preferred.

Responsibilities

• Ensure plant systems batch release & other relevant quality processes are compliant with regulations e.g.: 21CFR part 211.
• Serve as Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems.
• Serve as a Finished Product (FP) Process Representative or Site Clayton Process Representative as assigned.
• Drive improvement activities based on process performance, event response & process confirmation across FP, utilizing LEAN principles.
• Make decisions on quality & compliance issues with little guidance.
• Participate in process group activities as assigned & lead local implementations.
• Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs).
• Serve as the Subject Matter Expert (SME) of the multiple quality processes.
• Lead improvement activities/improvement of standards within the assigned process.
• Lead & coordinate batch release activities.
• Provide coaching to Site regarding quality & compliance related activities.
• Support, review & approve complex cross-functional investigations & root-cause analysis.
• Facilitate sharing of regulatory & compliance expectations.
• Review & approve complex DVs, CRs, SOPs, trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports.
• Eliminate non-value-added practices.
• Facilitate presentation, support & coaching for audits & inspections.
• Serve as Quality work package owner, or Quality approver of validation documentation.
• Review & approve complex Change Requests (CR's), Deviations (DVs), CAPAs & other documentation.
• Perform Self Audits (in conjunction with line of business (LoB)), QA presence & process confirmation on shop floor.
• Serve as Quality Risk Management Expert and responsible for development and leading and/or facilitating training.

Benefits

• 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.
• Family Focused Benefits including 12 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees