Quality Assurance Area Specialist III (QA for QC)

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 help improve the quality of life for millions of people around the world. In North Carolina, we operate three pharmaceutical manufacturing facilities responsible for different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals passionate about their work.

About the role

Ensures plant systems batch release and/or relevant quality processes are compliant with regulations. Has product release authority if the role involves batch release. Provides quality oversight, review, and approval of validation activities and documents associated with projects, new systems, changes to existing systems, and maintaining the validated state of equipment, processes, and systems. Supports and coaches during audits and inspections. Reviews and approves complex Change Requests (CR's), Deviations (DVs), CAPAs, and other documentation. Performs self-audits in conjunction with the line of business (LoB) and ensures Quality Assurance (QA) presence and process confirmation on the shop floor. Serves as a Site Clayton Process Representative, as assigned, supporting all processes and functions in the department. Trends and reports data as applicable.

Responsibilities

• Make decisions on quality and compliance issues with minimal guidance
• Participate in process group activities as assigned and lead local implementations
• Ensure site compliance with regulations, ISO/ISP standards, corporate, and local standard operating procedures (SOPs)
• Lead improvement activities and standards within the assigned process
• Review and approve change control documentation, SOPs, and other current good manufacturing practice (cGMP) documentation
• Provide coaching to the site regarding quality and compliance-related activities
• Support, review, and approve complex cross-functional investigations and root-cause analysis
• Facilitate sharing of regulatory and compliance expectations
• Review and approve complex DVs, CRs, SOPs, trend and report data for CAPA, Quality Management Reviews (QMRs), and Annual Product Review (APR) reports
• Eliminate non-value-added practices
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Requirements

• High School Diploma or equivalent (GED) required
• Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred; required if hired as an AQP
• Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility, and/or packaging systems, preferably in the pharmaceutical or medical device field
• Demonstrated expertise in regulations and quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT
• Quality Risk Management experience required
• Experience with regulatory requirements for computer systems, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity
• Experience in use of Risk Assessment and Vendor Assessments during evaluation of change controls, deviation, and validation activities
• Expert in cGMP documentation practices; minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred
• Excellent troubleshooting skills; ability to identify root cause of problems
• Demonstrated knowledge of critical controls and input/output requirements for processes in semi-finished manufacturing, finished manufacturing QC, IT, and process utilities preferred
• Excellent written and verbal communication skills
• Auditing experience with certification preferred (internal/external)
• Experience with LEAN, Six Sigma, and other continuous improvement methodologies
• Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process, or computer validation) preferred
• Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.)
• Expert in utilizing appropriate root-cause analysis tools and techniques preferred
• Experience with Risk Assessment and Risk Management
• Demonstrated excellence with time management, organizational, and project management skills

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to do close precision work with hands
• Must be able to remain in a stationary position (sitting and standing) 50% of the time
• May require corrected vision to 20/20 or 20/25 based on role
• May require color vision based on role
• May require the ability to work in loud noise environments with hearing protections

Benefits

• Leading pay and annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health, Dental, and Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• 14 weeks paid parental leave and 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards