Description

Performs GMP release and stability testing in Quality Control
Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses
Review of laboratory notebooks, protocols and reports
Perform day to day activities for cell propagation used for QC release and stability assays
Participate in technology transfer, method qualification and validation
Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines
Participate in internal assessments and regulatory audits as required
Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
Leading the lab in 5S and routine housekeeping activities
Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
Other duties as assigned

Responsibilities

Minimum of a degree or equivalent in a scientific discipline
Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
Hands on experience performing ELISA in a cGMP environment
Hands on experience performing SDS-PAGE in a cGMP environment
Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay
GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
Excellent analytical skills and knowledge
Strong troubleshooting skills for equipment and software
Solid ability to work independently (minimum supervision)
Ability to lead others, as needed
Ability to effectively collaborate with others
Excellent communications skills and be conversant in computer systems
Excellent multi-tasking and organizational skills.
Excels in time management
Strong attention to detail
Job holder should be a good understanding of relevant regulatory/industry standards and requirements

Hard Skills

Windows operating system
Document management
Cross-functional collaboration
Executive updates

Soft Skills

NOVAVAX

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Main info
Language English
Experience level Senior Level
Job type Full Time
Salary negotiable
CountryUnited States of America

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We offer

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Senior Quality Control Analyst

Description

Performs GMP release and stability testing in Quality Control

Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses

Review of laboratory notebooks, protocols and reports

Perform day to day activities for cell propagation used for QC release and stability assays

Participate in technology transfer, method qualification and validation

Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines

Participate in internal assessments and regulatory audits as required

Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures

Leading the lab in 5S and routine housekeeping activities

Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development

Other duties as assigned

Responsibilities

Minimum of a degree or equivalent in a scientific discipline

Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations

Hands on experience performing ELISA in a cGMP environment

Hands on experience performing SDS-PAGE in a cGMP environment

Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay

GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required

Excellent analytical skills and knowledge

Strong troubleshooting skills for equipment and software

Solid ability to work independently (minimum supervision)

Ability to lead others, as needed

Ability to effectively collaborate with others

Excellent communications skills and be conversant in computer systems

Excellent multi-tasking and organizational skills.

Excels in time management

Strong attention to detail

Job holder should be a good understanding of relevant regulatory/industry standards and requirements

Hard Skills

Soft Skills

We offer

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.