QA Specialist I-II

ALK-Abello, Inc•Post Falls, ID

2d•$55,000 - $65,000•Onsite

About The Position

ALK Source Materials, Inc., a leading manufacturer of quality allergenic biological source materials, and a member of the global ALK-Abello’ group of companies, is recruiting for our open Quality Assurance Specialist I-II position. Join our stable and growing company and provide leadership and expertise to our workforce located in our 150,000 square foot facility in Post Falls, ID. The Quality Assurance (QA) Specialist is responsible for quality oversight of business areas which require adherence to current good manufacturing practices associated with allergenic source material products. This position will provide support in managing the stability program, including sample submission for testing, authoring of protocols and reports, and data analysis. The position is also responsible for providing QA support for EUF, batch release, and general QA oversight. The Specialist is responsible for ensuring compliance to regulatory and quality systems requirements, through review and authorization of process and procedure changes, and deviation investigations. The QA Specialist works with multiple departments to build quality into solutions and improve the overall quality mindset. Other responsibilities also include some involvement in equipment qualification document review and authorization. All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

Requirements

Minimum of 5 years of hands-on experience in a regulated QA environment or laboratory setting.
Knowledge of scientific process and studies development.
Technical writing expertise.
Computer skills.
Strong attention to detail.
Ability to use critical thinking to provide problem resolution.
Clear and concise verbal and written communications.
Ability to maintain 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 and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

Nice To Haves

Bachelor’s degree in Biology, Microbiology, Chemistry, or a related field paired with a minimum of 2 years of relevant experience.
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.
Experience with SAP.

Responsibilities

Provide quality oversight of business areas requiring adherence to current good manufacturing practices associated with allergenic source material products.
Support the management of the stability program, including sample submission for testing, authoring of protocols and reports, and data analysis.
Provide QA support for EUF, batch release, and general QA oversight.
Ensure compliance to regulatory and quality systems requirements through review and authorization of process and procedure changes, and deviation investigations.
Work with multiple departments to build quality into solutions and improve the overall quality mindset.
Involve in equipment qualification document review and authorization.