Senior Quality Assurance Specialist

5 days ago


Warren, Michigan, United States Net2Source Inc. Full time

Overview:

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We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Net2Source Inc.

About the Role:

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The ideal candidate will have 2+ years of hands-on experience with bioanalytical techniques such as ELISA, Potency, Cell-based assays, etc. in a regulated environment (cGMP, cGLP).

Key Responsibilities:

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The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products.

This includes interfacing with multiple groups, independently performing tasks, interpreting results, and troubleshooting. Additionally, when needed, this position will assist with training and assay transfer.

Required Skills and Qualifications:

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* Hands-on experience with various bioanalytical techniques including ELISA, qPCR, FACS, and cell-based assays.

* Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.

* Ability to accurately understand, follow, interpret, and apply Global Regulatory and cGMP requirements.

* Technical writing skills.

* Problem-solving ability/mentality, technically adept, and logical.

Work Schedule and Benefits:

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This is a 12-month contract position with a competitive salary ($90,000 - $110,000 per annum) and benefits package. The work schedule is Mon-Fri, 8AM-4:30PM EST, and 100% onsite.

Education and Experience:

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Bachelor's degree required, preferably in Science. 2-3 years of relevant work experience in a regulated environment.

Salary Range:

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$90,000 - $110,000 per annum based on experience and qualifications.



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