Quality Assurance Operations Specialist Jobs in Alaska

Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.

Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.

Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

Continuously looking for opportunities to learn, build skills and share knowledge with others.

Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.

Ensure label requirements for each country are defined

8 years professional work experience in regulated industry with Bachelor's degree, or 10 years' experience with Associate’s degree

8 years professional experience in Quality role in pharmaceutical or biotech company

Ensure overall compliance of Clinical and Commercial products for all regions

Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls

Support product launch activities for introduction of product into new countries