Senior/Principal Quality Control Specialist, Investigations

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.

The opportunity:

Are you looking to join a team that drives positive change? The HTO Quality Control (QC) team is building our GMP and Digital Backbone team and is in search of a Lead Investigator. The Lead Investigator will work closely with QC Operations, QC Support Teams, QC Leaders and other site functions to craft, standardize and complete the business processes that support routine QC operations. As a Lead Investigator, you will be responsible for handling flow of work (standard and unexpected) through the functional teams that conduct Deviations, Investigations, complete Corrective and Preventive Actions, implement technical/process changes, complete Lab Support activities and deploy Master Data changes to ensure on time and in full delivery of QC commitments.

• 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.

Who You Are

• You hold a Bachelor's of Science degree with 4-7 years of experience for the Senior level and 8-11 years of experience for the Principal level in the pharmaceutical or scientific industry.

• You have significant experience working in a cGMP or similarly regulated environment

• You possess a deep understanding of QC practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks.

• You have the judgment / discretion to advance matters of significance, ensuring efficient testing operations and regulatory compliance.

• You possess outstanding social skills and strong written and verbal communication skills. You use these skills to build effective multi-functional teams and commit to timely informed decisions and completion of simple to moderate actions from others.

• You have a passion and ability for mentoring and encouraging others and are able to build/ maintain effective multi-functional teams without direct management responsibilities.

• You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)

• You may be required to lift up to 25lbs

• You may have to work with hazardous materials and chemicals.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $68,000 - $126,000 for the Senior level and $90,200 - $167,310 for the Principal Level . Actual pay will be determined based on experience, level, 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.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.