QC Senior​/Principal Specialist - CLO Oversite

The Position

In this exciting opportunity you will join a team that is expanding and transferring CLO activities to our Quality Control Lab. There is the potential to help establish HTO as a center of excellence for the North American network. In this role, you will be the CLO and External Quality primary contact for QC related CLO activities. This role will give you the ability to use your expertise and mentor/train others.

In addition to performing and reviewing protocols, the individual must be able to interpret data, troubleshoot failures and equipment issues while adhering to strict guidelines on cGMP documentation. The individual will support planned events/unplanned events/out-of specification investigations, risk assessments, audits, and collaborate with internal and external groups to identify improvement opportunities in technology and business processes.

• 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.
• Leading, forecasting and coordinating activities between HTO QC and CLOs. Including executing and reviewing contracts, audits, methods, transfers and data. You will be a subject matter expert on these methods and activities.

• You have a clear Customer Focus and are looking ahead to anticipate future stakeholder needs.
• You are a team player and contribute to an environment of strong team spirit, high motivation and delivery with a sense of urgency.
• You have excellent verbal and written communication skills which enable you to synthesize data, processes and information - summarizing complex matters in simple terms and have a good understanding of a complex organization.
• You embody PT lean principles and methods while fostering a mindset of quality, innovation and continuous improvement throughout the organization by encouraging experimentation and learning.
• You are able to nurture an environment where people feel included, feel safe to learn through experimentation, feel able to be themselves and have the opportunity to do their best work.
• You have demonstrated business acumen and experience which is foundational to your solution-oriented attitude and your ability to stay focused in ambiguous and pressured situations.

• SE6:
  Bachelor’s of Science degree with 8-11 years of dynamic experience in the pharmaceutical or scientific industry or 6-8 years of experience with a graduate degree. 3 years of experience working in a cGMP or similarly regulated environment is required.
• SE7:
  Bachelor’s of Science degree with 15+ years of experience in the pharmaceutical industry or 13+ years with a Graduate degree. 3+ years of experience working in a cGMP or similarly regulated environment.

• 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.

The expected salary range for the Sr Level (SE6) based on the primary location of Oregon is $90,090 to $167,310. Actual pay will be determined based on experience, qualifications, geographic…