QA Specialist I-II

Quality Assurance Specialist I-II

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, .

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.

The successful candidate will have a minimum of 5 years of hands-on experience in a regulated QA environment or laboratory setting. We highly value the deep expertise that comes from real-world, practical experience, so a formal degree is not required. However, we also welcome candidates who bring a Bachelor's degree in Biology, Microbiology, Chemistry, or a related field paired with a minimum of 2 years of relevant experience.

Knowledge of scientific process and studies development, technical writing expertise and computer skills are required. Experience with Quality Systems and Regulatory requirements such as: GMP, GCP, GLP, GPvP, FDA, ICH, European Authority in allergenic and/or biologic quality systems is highly preferred.

The candidate must have strong attention to detail and be able to use critical thinking to provide problem resolution. Must have clear and concise verbal and written communications while maintaining professionalism and approachability to work effectively with internal and external customers. Must have the ability to drive projects and manage both project and daily tasks. Experience with quality management of computerized systems, including computerized system validation and SAP is a plus.

All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

ALK, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.