Review/approval of NCs, approval of Change Requests/SOPs, review/approval of Training Material, approval of Laboratory Investigations (FP- IQC), approval of Trend Reports, Supplier Program Management, performs Self Audits (in conjunction with LoB), QA presence & process confirmation on shop floor, improvement to Q processes.
* Ensure site compliance with Regulations, ISO standards, & corporate & local SOPs.
* Review & approve change control requests.
* Participate in project teams as the compliance resource.
* Provide guidance to departments regarding quality-related activities.
* Support, review & approve cross-functional investigations & root-cause analysis.
* Participate in process confirmations & Go Look Sees.
* Participate in knowledge & experience sharing with other QA Compliance Specialists to assure compliance with company procedures, policies & objectives.
* Evaluate trend & report data for QMRs & APR reports.
* Perform other duties as assigned.
BA/BS degree in Life Sciences, Engineering, or related field.
* 4 years of QA &/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
* General knowledge of regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Supplier Management, Project Management, etc.)
* Familiarity with local processes & quality systems.
* Demonstrated knowledge of critical controls & input/output requirements for NNPII processes.
* Knowledge of Quality, Aseptic Production, Business Support, QC, O&P &/or Finished Production processes.
* Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in aseptic manufacturing.
* Excellent written & verbal communication skills.
* Basic computer skills in MS Office, MS Project, PowerPoint, etc.
* Auditing experience with certification preferred.
* Experience in the use of Six Sigma & LEAN tools.
Physical & Other Requirements:
* Normal office working environment.
* Must be willing to work hours necessary to support a 24/7 operation.
* Must be able to travel internationally.
Department QA Compliance
Position Location US - Clayton, NC
State/Provinces US - NC
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information....cont.