Temporary Product Quality Assurance Specialist I-II

ALK-Abello, Inc • Post Falls, ID

15h

About The Position

ALK Source Materials, Inc. (ASM), a leading manufacturer of quality allergenic biological source materials, and a member of the global ALK group of companies, is recruiting for our open Product Quality Assurance (PQA) Specialist I/II position. This position is a full-time, four-year assignment to support expansion projects. Join our stable and growing company and provide leadership, mentorship, and expertise to our workforce located in our 120,000 square foot facility in Post Falls, ID.

The Product Quality Assurance (PQA) Specialist is a member of ALK’s Quality Assurance (QA) department. They are responsible for providing QA support for batch release and general QA oversight. The associate is responsible for ensuring compliance to regulatory and quality systems requirements, through batch review and release, review and authorization of process and procedure changes, and deviation investigations. Responsibilities also include some involvement in equipment qualification review and authorization.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry or related field
• minimum of 2-5 years of relevant experience in a regulated environment or laboratory setting, or a combination of relevant education and experience
• Knowledge of scientific process and studies development
• technical writing expertise
• computer skills
• strong attention to detail
• be able to use critical thinking to provide problem resolution
• clear and concise verbal and written communications while maintaining professionalism and approachability to work effectively with internal and external customers
• ability to drive projects and manage both project and daily tasks
• ability to comfortably work around live, stinging insects, allergenic antigens, hazardous chemicals, solvents, and laboratory reagents

Nice To Haves

• Experience with Quality Systems and Regulatory requirements such as: GMP, GCP, GLP, GPvP, FDA, ICH, European Authority in allergenic and/or biologic quality systems
• Experience with quality management of computerized systems, including computerized system validation and SAP

Responsibilities

• providing QA support for batch release
• general QA oversight
• ensuring compliance to regulatory and quality systems requirements, through batch review and release, review and authorization of process and procedure changes, and deviation investigations
• involvement in equipment qualification review and authorization

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level