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Lykan Bioscience - Now RoslinCT · 3 weeks ago

Lead QC Analyst, Raw Materials, Cell Therapy

Hopkinton, MA, US

Full-time

Onsite

Senior Level

$85K/yr - $115K/yr

5+ years exp

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. The Quality Control/ Raw Material Lead Analyst will be responsible for supporting the inspection and release of various incoming raw materials for use in the manufacturing of cell therapy products, ensuring compliance with applicable quality systems and cGMPs.

BiotechnologyManufacturing

Responsibilities

Support QC Raw Materials program by performing raw material inspection/sampling (as needed)/approvals per written procedures

Assist in completing material onboarding assessments, classifications and safety assessments (as applicable)

Sample management activities-maintain quarantine, released, retain, and testing material inventory (spreadsheets)

Maintain QC RM monthly metrics

Perform risk assessments, create and develop material specifications and testing requirements (as needed)

Develop programs for raw material qualification and monitoring of compendiaI updates

Support material testing for external contract testing laboratories (quotes, shipping and test results, etc.)

Support QC for material Supplier Change Notifications and attend Material Review Board meetings, as needed

Write and/or review protocols, test methods, and reports in support of analytical methods for cell therapy products

Perform non-routine/routine QC testing for analytical methods in support of cGMP manufacturing of cell therapy products (in-process, raw material, final product or stability) as needed

Support analytical equipment installation and qualification, ensuring 21 CFR Part 11 compliance, as needed

Participate as raw material method subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations

Work collaboratively with cross functional departments including but not limited to Warehouse, Supply Chain, Supplier Quality, Quality Assurance, and Program Management

May interact with external partners on technical matters in relation to raw materials or analytical methods

Write/revise QC specific material specifications, procedures and protocols

Possess the ability to evaluate various Quality Certificates of chemicals/raw materials/packaging components

Adhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materials

Other duties as assigned

Qualification

GMP QC laboratory experienceAnalytical method knowledgeRaw material testingANSI.ASQ Z1.4 sampling plansPHOsmolality testingEffective communication skillsProblem-solving skillsTeamwork skillsDetail-oriented