Overview
SR Associate, Gene Therapy Quality Control Jobs in Andover, Massachusetts, USA at Orbis Clinical
SR Associate, Gene Therapy
Quality Control
Job Title:
Contract Senior Associate, Gene Therapy Quality Control
Location:
Andover, MA (Onsite 5 days/week)
Contract:
12 months
The Importance of the Role
This individual will support quality control activities to support a centralized program management of reference standards and critical reagents used across a wide network of QC labs in the testing and release of clinical and commercial products.
The work involves generation and qualification of critical reagents, maintaining inventory, qualification, stability tasks to support AAV-based product testing at Andover company site and at contract labs. The individual will conduct laboratory support processes such as maintaining cell cultures. The candidate must have hands-on experience in cell culture techniques, in vitro Potency, Western blot (automated preferred), protein extraction, and protein quantification methods.
Experience with qPCR, and/or ddPCR are also desired skills. The work involves performing assays in a QC-GMP BSL-2 environment.
The individual will support the team manager in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner.
Primary Responsibilities Include:
Lead the lab activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material.
Lab work includes, not limited to performing Nanodrop UV/Vis and Agarose Gel testing, qPCR and ddPCR assays, JESS analysis, as appropriate, to qualify standards and support stability studies.
Prepare, qualify, and release standards for the in vitro potency methods and titer methods.
Design, screen, and document PCR primer/probes to be used in quantification of viral vectors as needed.
Monitor, compile, and review analytical and QC data individually and with team members.
Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
Create and maintain clear and concise records and documentation.
Trend data for qualified materials, release products, and stability products.
Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
Perform other related duties incidental to the work described.
Seniority level
Associate
Employment type
Contract
Job function
Other and Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Title: SR Associate, Gene Therapy Quality Control
Company: Orbis Clinical
Location: Andover, Massachusetts, USA
Category: Quality Assurance – QA/QC, Healthcare
