THE POSITION

Please note there are two available opportunities and could be hired at either the Senior or Principal QA Specialist level.
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Quality Control organization at HTO comprises approximately 50 employees organized in five departments and is a central key point for the manufacturing of high quality medicines. Together, we produce life-saving medicine every year to patients around the world.

• You will lead / perform cross functional major/critical Quality Control Investigations (e.g.: Out of Specifications, Out of Expectations, Over Action Limits, local and global process deviations) using established Root Cause Analysis tools and data-based impact assessments within established timelines.
• You will develop, in collaboration with key partners and action owners, comprehensive and effective Corrective and Preventive Action Plans. You will drive completion of actions through self or others with tact and effective communication skills.
• You will lead/participate in cross functional teams that ensure safety, quality, delivery, engagement and cost objectives are sustained / exceeded. You will own, delegate and/or drive actions that result from these teams.
• You will author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments.
• You will be a resource for colleagues with less experience and actively provide guidance to peers and other leaders to grow their knowledge and independence.
• You will serve as a subject matter authority for the quality organization or the site on matters pertaining to policies, programs, practices and objectives within their area of expertise.
• You will lead minor to moderate projects or participate in project teams to deploy new systems or business processes, as assigned