This listing was posted on Tip Top Job.
Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus)
Location:
Durham, NC
Description:
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 and obesity. Beingpart 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 : Oral Finished Products 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. OFP 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 12 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 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 Performs quality review and approval of Batch Production Records (BPRs), Change Requests (CRs), Deviations and other documentation (in conjunction with LoB) and QA presence and process confirmation on shop floor. Handles release of raw materials and provides quality oversight, review and approval of validation activities associated with minor changes to existing systems. Performs archiving duties and QA presence and process confirmation on shop floor. Relationships Manager, Quality Assurance. Essential Functions :Ensures site compliance with Regulations, ISO standards, corporate and local SOPs:Reviews and approves documentation for Quality approval : components/raw material, batch records, change control requests, deviations and validation documents:Performs QA presence and process confirmation on shop floor:Participates in project teams as a quality resource:Supports, reviews and approves investigations and root:cause analysis:Participates in process confirmations and Go Look Sees:Evaluates trend and report data for QMRs and APR reports:Other accountabilities, as assigned. Physical Requirements Occasionally moves equipment and /or supplies weighing up to 33 pounds. Ability to work in an open office environment with the possibility of frequent distraction. Ability to work the hours necessary to support a 24/7 continuous manufacturing operation. Ability to adjust schedule to work with colleagues in other international time zones. Some roles require ability to work 12:hour shifts or longer, day or night. Ability to travel domestically and /or internationally, as necessary. Qualifications :Bachelor's degree in life sciences or related field of study from an accredited university required:With P and O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate:Minimum of three (3) years of QA and /or quality related experience required, preferably in the pharmaceutical or medical device industry:Understanding of cGMP manufacturing and production processes and how required:Understanding of the Batch Review Processes required:Understanding of validation preferred:Understanding of quality management systems required:Understand
Posted:
May 1 on Tip Top Job
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Tip Top Job
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus)
Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus) is a Quality Assurance QA Job located in Durham NC. Find other listings like Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus) by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus) is a Quality Assurance QA Job located in Durham NC. Find other listings like Quality Assurance Area Specialist II : OFP 2nd Shift ( Release Focus) by searching Oodle for Quality Assurance QA Jobs.