QC Specialist, Master Data jobs in United States
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Roche · 16 hours ago

QC Specialist, Master Data

Roche is a leading pharmaceutical company committed to delivering life-saving medicines. The QC Specialist, Master Data will manage and improve Master Data supporting Quality Control operations, collaborating with various departments to ensure data integrity and compliance.

BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
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Comp. & Benefits
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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 RegulationsAnalytical Equipment AdministrationCorrectivePreventive ActionsLabware LIMSSAPCurious MindsetCommunication SkillsProblem SolvingTeam Collaboration

Required

You hold a 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
You possess a working understanding of database management/relational tables, Operational Excellence tools, cGMP regulations and industry guidelines related to biological processing
You 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
You are 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
You have 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
You have a curious open mindset and continuously share information with others as a means to foster effective cross functional teams

Preferred

We would be even more delighted, if you have 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

Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.

H1B Sponsorship

Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)

Funding

Current Stage
Public Company
Total Funding
$7.79B
Key Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M

Leadership Team

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Alan Hippe
Member of the Executive Board - Group CFO
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Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
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Company data provided by crunchbase