QA Area Specialist II - SDF (3rd shift)

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. 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 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 the 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 Equal Opportunity Nuevo 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. #J-18808-Ljbffr Initial Therapeutics, Inc.