The Opportunity:
The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)
Responsibilities:
Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures.
Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.
Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation.
Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes.
Ensure maintenance and calibration of laboratory equipment and systems.
Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required.
Who you are:
(Minimum Requirements)Work Environment/Physical Demands/Safety Considerations:
Work in an office and laboratory environment
Lift up to 25 lbs may be required.
Ability to sit, stand, and move within work space for extended periods
May be required to sit at a computer terminal for extended periods.
Working location is Onsite.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Oregon is $64,800.00 - $100,500.00 Annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
