QC Specialist, Master Data

Genentech • Hillsboro, OR

1d • $98,000 - $182,000 • Onsite

About 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:
Do you have a passion for consistent data and understand how this can be achieved through clear and consistent Master Data? Are you a problem solver that believes most or all issues can be linked to a process flaw? Then you may be the person we are looking for. The HTO Quality Control (QC) Team is looking for an individual interested in managing simple to moderately complex sets of Master Data that support QC operations. This role will collaborate with internal and external departments (e.g. QC Operations, Database System Developers, Business Analysts, Manufacturing, Packaging, External Quality, Control System Scientists, Product Technical Leads etc.) to maintain and improve contemporary relevance of QC Master Data. This role will gain a deeper understanding of how the master data is utilized and how it can be improved as they own/perform activities that support/improve lab operations using Good Manufacturing/Laboratory Practices. These activities will include conducting minor deviation investigations, owning Corrective and Preventive Actions (CAPAs), owning Change Request Actions, performing periodic reporting, data review and generation of certificates of test/analysis, direct material release, and analytical equipment administration.
You will create, update, test various sets of Master Data and end-user defined system settings that enables consistent execution, collection, transaction, storage, analysis, and reporting of analytical/microbiological tests and activities performed by Quality Control Operations. Supported Software Systems include: Labware LIMS, Biovia, Molecular Devices SoftMax Pro, SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System, Veeva, and ValGenesis.
You will be the site representative on System Enhancement Teams and User Communities of Practice Teams, communicate system changes and best practices to local system users and coordinate initial and maintain continuous end user training materials/content for supported systems.
You will perform Direct Material Release and review / generate Drug Product Certificates of Analysis, as needed.
You will lead or participate in minor 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 generating data-based impact assessments within established timelines.
You will collaborate with key stakeholders to identify and execute Corrective and Preventive Action Plans, completing assigned actions through self or others with tact and effective communication skills.
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 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.

Requirements

• Bachelor’s of Science degree with 4-7 years of experience in the pharmaceutical industry, quality control and/or database management or 8+ years of experience with an Associates/Vocational Degree. 3 years of experience working in a cGMP or similarly regulated environment is required.
• Working understanding of database management/relational tables, Operational Excellence tools, cGMP regulations and industry guidelines related to biological processing.
• Work independently within standard operating procedures, guidelines, and policies to execute role based accountabilities and have the judgment / discretion to escalate matters of significance in a timely manner, ensuring efficient operations and regulatory compliance.
• Able to assess various changes/issues related to quality control or database management to define/determine next actions required to bring about a desired outcome or mitigate risks associated with these changes/issues to the QC organization.
• Strong verbal and written communication skills with ability to summarize minor to moderate problems that drive timely informed decisions and completion of simple to moderate actions.
• Curious open mindset and continuously share information with others as a means to foster effective cross functional teams

Nice To Haves

• Experience building reporting tools such as tableau dashboards.

Responsibilities

• Create, update, test various sets of Master Data and end-user defined system settings
• Site representative on System Enhancement Teams and User Communities of Practice Teams
• Perform Direct Material Release and review / generate Drug Product Certificates of Analysis, as needed
• Lead or participate in minor Quality Control Investigations
• Collaborate with key stakeholders to identify and execute Corrective and Preventive Action Plans
• Author, review, and/or approve various business process & compliance related documents
• Participate in cross functional teams that ensure safety, quality, delivery, engagement and cost objectives are sustained / exceeded

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level