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QA Area Specialist I - SDF (1st shift)
- Durham, North Carolina, United States
- Durham, North Carolina, United States
Über
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
Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOP's) and guidance. Accountable for Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (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 – batch records and other documentation Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement Participate in process confirmations & Go Look Sees Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports Perform QA role to review and approve local production related Customer Complaint Investigations (escalate if necessary) Participate in & support the audit management team as needed during internal, external audits and inspections Responsible for training of AP and FP members responsible for conducting investigations 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 May require the ability to work in loud noise environments with hearing protections Qualifications
Associate’s degree in life sciences or related field from an accredited college required; Bachelor’s degree preferred May consider a High School Diploma or GED with a minimum of six (6) years of experience in QA or related quality experience Minimum of two (2) years QA and /or quality related, or API experience required, preferably in the pharmaceutical industry Quality Experience preferred General knowledge of pharmaceutical regulations & quality systems preferred Knowledge of Quality and one or more of the following: Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, API, and/or Finished Production processes preferred Excellent written & verbal communication skills required Basic computer skills in MS Office, MS Project, PowerPoint, etc. Required 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.
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Sprachkenntnisse
- English
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