Quality Control Analyst

3 weeks ago

Hillsboro, United States Genentech Full time
The Position

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 Operations organization at HTO is divided into three value streams, which combine to produce millions of units of 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 Process & Compliance team and is in search of a Technical Lead. The Technical Lead will work closely with QC Operations, QC Support Teams, QC Leaders and other Value Stream team members to craft, standardize and complete the business processes that support routine QC operations. As the Technical Lead, you will be responsible for handling flow of work (standard and unexpected) through the functional teams that conduct Deviation 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.

Job Functions
  • 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 perform Direct Material Release and review / generate Drug Product Certificates of Analysis, as needed.
  • 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 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 is required.
  • You possess a deep understanding of Operational Excellence practices, cGMP regulations and industry guidelines related to biological processing. You consistently apply this understanding when implementing / or developing operational procedures/activities.
  • You have practical or strong theoretical experience with operating / troubleshooting analytical equipment, biological test methods, general chemistry test methods and/or building/maintaining complex database systems and use this experience to make sound supported decisions.
  • You are a strong problem solver and have the demonstrated ability to troubleshoot process related issues.
  • You have the judgment / discretion to raise matters of significance, ensuring efficient operations and regulatory compliance.
  • You have excellent verbal and written communication skills with proven ability to consistently pitch/summarize complex problems to various partner levels (executive management to peers) to drive timely informed decisions and completion of simple to complex interrelated actions.
  • You have a passion and ability for mentoring and inspiring others and are able to build/ maintain effective cross functional teams without direct management responsibilities.


Work Environment/Physical Demands/Safety Considerations
  • 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 will work on/interact with computerized systems/screens for long periods of time (6-8 hours)
  • 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 of Hillsboro, Oregon is $113,000 to $209,800. 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.

Link to Benefits

Relocation benefits are available for this position.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

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