Quality Assurance Area Specialist I

Novo Nordisk A/S; Durham (NC); On-site; USD 50,000 - 95,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Area Specialist I to ensure compliance with regulations and quality processes in their Durham facility. This role involves reviewing and approving Batch Production Records, supporting investigations, and participating in process confirmations. With a focus on improving the quality of life for patients, this position offers a chance to contribute to life-changing treatments in a collaborative environment. If you have a passion for quality assurance and a background in life sciences, this is an exciting opportunity to advance your career in a leading pharmaceutical company.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Minimum of one year of QA and/or cGMP experience required.

Responsibilities

• Ensure compliance with regulations and quality processes.
• Review and approve Batch Production Records and documentation.

Skills

Quality Assurance

cGMP knowledge

Batch Review Processes

Root-cause analysis

Multi-tasking

Education

Bachelor’s degree in life sciences

Equivalent combination of education and experience

Tools

MS Office

PowerPoint

Word

Excel

Job description

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Quality Assurance Area Specialist I - Batch Release Records

Facility: Quality

Location: Durham, NC, US

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies - Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes.

The Position

Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Performs quality review & approval of Change Requests (CR's) & other documentation (in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. This position works closely with production. The schedule is Monday - Thursday working 10hr day shift.

Essential Functions

• Ensures site compliance with Regulations, ISO standards, corporate & local SOPs
• Reviews & approves documentation for Quality approval – batch records & other documentation
• Supports & reviews investigations & root-cause analysis
• Participates in process confirmations & Go Look Sees
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

May move equipment &/or supplies weighing up to 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.

Qualifications

• Bachelor’s degree in life sciences or related field of study from an accredited university required
• With P&O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate
• Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry
• General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred
• General knowledge of quality oversight & on floor production support preferred
• Basic computer skills in MS Office, PowerPoint, Word, Excel, etc. required
• Knowledge of cGMPs in manufacturing required, pharmaceutical manufacturing preferred
• Knowledge of Quality & Production processes required
• Sets goals & prioritizes tasks for own work on short-term basis, meets deadlines & makes regular progress reports on performance
• Performs well with multi-tasking
• Adjust priorities in accordance with changing circumstances

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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.