What are the responsibilities and job description for the QA Area Specialist II - SDF (3rd shift) position at BioSpace?
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 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. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.
What We Offer You
Leading pay and annual performance bonus for all positions
All employees enjoy 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 & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence & process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Perform archiving duties & QA presence & process confirmation on shop floor.
Relationships
Reports to Manager, Quality Assurance.
Essential Functions
Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents
Perform QA presence & process confirmation on shop floor
Participate in project teams as a quality resource
Support, review & approve investigations & root-cause analysis
Participate in process confirmations & Go Look Sees
Evaluate trend & report data for QMRs & APR reports
Follow all safety & environmental requirements in the performance of duties
Other duties 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 required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role.
Qualifications
Bachelor’s degree in life sciences or related field of study from an accredited university required
May consider an Associate’s degree in life sciences or related field from an accredited college with a minimum of five (5) years of experience in QA or related quality experience
May consider a High School Diploma or GED with a minimum of seven (7) years of experience in QA or related quality experience
Minimum of three (3) years of QA &/or quality related or API experience required, preferably in the pharmaceutical industry
Understanding of cGMP manufacturing & production processes & how to apply required
Understanding of the Batch Review Processes required
Understanding of validation preferred
Understanding of quality management systems required
Understanding of quality oversight & on floor production support required
Knowledge in Quality Management Systems required
Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred
Excellent written & verbal communication skills required
Basic computer skills in MS Office, MS Project, PowerPoint, etc. Required
Auditing experience with certification a plus
Experience in the use of Six Sigma & LEAN tools a plus
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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 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. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.
What We Offer You
Leading pay and annual performance bonus for all positions
All employees enjoy 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 & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence & process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Perform archiving duties & QA presence & process confirmation on shop floor.
Relationships
Reports to Manager, Quality Assurance.
Essential Functions
Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents
Perform QA presence & process confirmation on shop floor
Participate in project teams as a quality resource
Support, review & approve investigations & root-cause analysis
Participate in process confirmations & Go Look Sees
Evaluate trend & report data for QMRs & APR reports
Follow all safety & environmental requirements in the performance of duties
Other duties 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 required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role.
Qualifications
Bachelor’s degree in life sciences or related field of study from an accredited university required
May consider an Associate’s degree in life sciences or related field from an accredited college with a minimum of five (5) years of experience in QA or related quality experience
May consider a High School Diploma or GED with a minimum of seven (7) years of experience in QA or related quality experience
Minimum of three (3) years of QA &/or quality related or API experience required, preferably in the pharmaceutical industry
Understanding of cGMP manufacturing & production processes & how to apply required
Understanding of the Batch Review Processes required
Understanding of validation preferred
Understanding of quality management systems required
Understanding of quality oversight & on floor production support required
Knowledge in Quality Management Systems required
Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred
Excellent written & verbal communication skills required
Basic computer skills in MS Office, MS Project, PowerPoint, etc. Required
Auditing experience with certification a plus
Experience in the use of Six Sigma & LEAN tools a plus
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.