Quality Assurance Area Specialist II (QA for FP)

About the Role

Ensure Batch Production Records (BPRs) and relevant quality processes are compliant with regulations and associated corporate and local standard operating procedures (SOPs). Oversee the release of raw materials, quality oversight, review, and approval of validation activities for minor changes to existing systems. Review periodic system evaluations to maintain validated state. Perform quality review and approval of Change Requests (CR's), Deviations, and other documentation. Conduct Self Audits in conjunction with the line of business (LoB), provide Quality Assurance (QA) presence, and perform process confirmation on the shop floor with stakeholders.

Responsibilities

• Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate, and local SOPs.
• Review and approve documentation for Quality approval, including components/raw material, batch records, change control requests, deviations, Quality Control (QC) laboratory investigations, SOPs, and validation documents.
• Participate in project teams as a quality resource.
• Support, review, and approve investigations and root-cause analysis using LEAN tools and continuous improvement techniques.
• Participate in process confirmations and Go Look Sees.
• Evaluate trend and report data for Quality Management Reviews (QMRs) and Annual Product Review (APR) reports.
• Follow all safety and environmental requirements in the performance of duties.
• Other accountabilities, as assigned.

Physical Requirements

• May move equipment and/or supplies weighing up to thirty-three (33) pounds within the facility using various body positions.
• May be required to be on your feet for up to a 12-hour shift.
• 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.

Requirements

• High School Diploma (GED) required.
• Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred.
• Minimum of four (4) years of QA and/or quality-related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required.
• General knowledge of regulations and quality systems (e.g., product disposition, deviations, Change Control, Audits, Supplier Management, Project Management, etc.) preferred.
• Familiarity with local processes and quality systems preferred.
• Familiarity with risk assessment/risk management preferred.
• Demonstrated knowledge of critical controls and input/output requirements for NNPILP processes preferred.
• Knowledge of Quality, Aseptic Production, Business Support, QC, IT, Facilities/Utilities, warehousing/logistics, O&P, and Finished Production processes preferred.
• Knowledge of US, EU regulations and guidelines, ISO standards, and application of Good Manufacturing Practices (GMPs) preferred.
• Excellent written and verbal communication skills required.
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required.
• Auditing experience with certification required.
• Experience in the use of Six Sigma and LEAN tools required.

Skills

• Sets goals and prioritizes tasks for own work on a short-term basis required.
• Meets deadlines and makes regular progress reports on performance required.
• Keeps track and informs management about fluctuation in workload required.
• Performs well with multitasking required.
• Adjusts priorities in accordance with changing circumstances required.

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 14 weeks paid parental and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition Assistance.
• Life and Disability Insurance.
• Employee Referral Awards.

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 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 what they do.