Quality Control Specialist jobs in United States
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AskBio Inc. · 4 hours ago

Quality Control Specialist

AskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Quality Control Specialist will perform routine GMP testing activities in a regulated gene therapy manufacturing environment, ensuring data integrity and compliance within the QC laboratories.

BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques
Prepare solutions and maintain cell lines for various clinical programs
Prepare laboratory solutions, maintains cell lines, and other day to day laboratory activities
Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data
Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records
Assist with management of analytical test method supplies and samples as needed
Ensure lab areas are clean and organized, maintaining equipment and consumables
Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
Participate in continuous improvement projects in the AD and QC labs
Support revisions to work instructions, SOPs, forms, protocols, and reports

Qualification

CGMP Quality ControlCell-based assaysPCR testingLIMS systemAnalytical testingCollaborative relationshipsCommunication skillsProject managementIndependent work

Required

Bachelor's degree in biology or related field
Excellent verbal and written communication skills
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team
Ability to handle multiple projects/teams simultaneously
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision

Preferred

Relevant work experience in cGMP regulated Quality Control laboratory
Experience working for a pharmaceutical or biotech company
GDP experience
Experience with cell-based assays and PCR testing
Experience working within a cGMP Quality Control LIMS system

Company

AskBio Inc.

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AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives.

H1B Sponsorship

AskBio Inc. 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
2024 (1)
2023 (4)
2022 (8)
2021 (3)
2020 (3)

Funding

Current Stage
Late Stage
Total Funding
$241.76M
Key Investors
Scottish Enterprise
2020-10-26Acquired
2020-09-02Grant· $2.66M
2019-04-11Private Equity· $235M

Leadership Team

S
Samuel Hopkins
Sr. Vice President, Therapeutics
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Mansuo L Shannon
Board Member
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Company data provided by crunchbase