QC Reviewer, Stability at Thermo Fisher Scientific

Foster City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

NoVisa

Pharmaceutical, Biotechnology, Life SciencesIndustries

Requirements

Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Bachelor's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience

Responsibilities

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness
Validates large and/or non-routine projects
Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness
Determines whether laboratory staff effectively validated a particular method
Reviews sample results for completeness and accurate representation of the data and reports findings
Provides expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions
Communicates with laboratory staff to proactively address the quality of laboratory documentation
Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction
Trains new QC Reviewers and laboratory staff
Assists the departmental manager or supervisor in the evaluation of the laboratory QC program. Helps maintain compliance and assists in continuous improvement of laboratory processes
Performs other duties as assigned
Perform data analysis using JMP and Discoverant for quarterly trending and regulatory submissions
Generate Stability Summary Reports (SSRs) from LIMS for regulatory filings and inquiries, and Shelf-life extensions
Verify data for non-regulatory reports and support information gathering for stability-related investigations
Maintain and update molecule-specific stability trackers and shipping forecasts using Smartsheets and internal systems
Draft temperature excursion memos and initiate stability studies through protocol creation and revision
Populate and manage trackers for biologics programs and monitor material transfer reports
Collaborate with stability leads to ensure timely and compliant execution of stability program deliverables

Skills

Key technologies and capabilities for this role

analytical data reviewQC reviewstability testingSOP compliancelaboratory data evaluationanalytical methodspharmaceutical analysisbiopharmaceuticaldata validation

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a fully onsite role based at our customer’s site in Foster City, CA, and we welcome applicants from all locations within the US.

What are the key responsibilities of the QC Reviewer role?

The role involves performing complex analytical data review for compliance with methods and SOPs, validating projects, reviewing sample results, providing expert knowledge in analytical techniques, communicating with lab staff, preparing QC statements, training staff, and assisting in lab QC program evaluation.

What is the salary or compensation for this position?

This information is not specified in the job description.

Does the company offer relocation assistance?

Relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

What qualifications or requirements are needed to apply?

Candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, which includes a drug screening.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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