QA Area Specialist I - SDF (2nd shift)

About the role

The QA Area Specialist I is responsible for ensuring compliance with regulations and SOPs, reviewing and approving documentation, supporting investigations, and performing self-audits and process confirmations.

Responsibilities

• Ensure site compliance with Regulations, ISO standards, and corporate/local SOPs
• Review and approve documentation for Quality approval – batch records and other documentation
• Support, review, and 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

Qualifications

• Associate’s degree in life sciences or related field from an accredited college required. Bachelor’s degree preferred
• 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

Benefits

Leading pay and annual performance bonus for all positions
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