QC Specialist, Master Data jobs in United States
info-icon
This job has closed.
company-logo

Genentech · 5 hours ago

QC Specialist, Master Data

Genentech is a leading pharmaceutical company focused on drug product and finished goods manufacturing. They are seeking a QC Specialist to manage Master Data that supports Quality Control operations, collaborating with various departments to improve lab operations through effective data management and compliance with Good Manufacturing Practices.

BiotechnologyLife ScienceManufacturing
check
Comp. & Benefits
check
H1B Sponsor Likelynote

Responsibilities

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
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

Qualification

Database ManagementCGMP RegulationsQuality ControlLabware LIMSSAPAnalytical EquipmentCommunication SkillsProblem SolvingTeam Collaboration

Required

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
Working understanding of database management/relational tables, Operational Excellence tools, cGMP regulations and industry guidelines related to biological processing
Ability to work independently within standard operating procedures, guidelines, and policies
Strong verbal and written communication skills with ability to summarize minor to moderate problems
Curious open mindset and continuously share information with others

Preferred

Experience building reporting tools such as tableau dashboards

Benefits

Relocation benefits are available for this position.
A discretionary annual bonus may be available based on individual and Company performance.

Company

Genentech

company-logo
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.

H1B Sponsorship

Genentech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)

Funding

Current Stage
Public Company
Total Funding
unknown
2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown

Leadership Team

leader-logo
Ashley Magargee
Chief Executive Officer
linkedin
leader-logo
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
linkedin
Company data provided by crunchbase