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Abeona Therapeutics · 1 month ago

Specialist I, Quality Assurance - Quality Operations

Cleveland, OH

Full-time

Onsite

Entry Level

$60K/yr - $77K/yr

1+ years exp

Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. The Specialist I, Quality Assurance will perform routine activities associated with manufacturing of cell and gene therapy products, supporting quality systems in a cGMP environment.

BiotechnologyGeneticsHealth CareManufacturingMedical Device

Comp. & Benefits

No H1B

Responsibilities

Process document control requests and issue-controlled forms, logbooks, notebooks, master production records, labels, and protocols

Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols

Coordinate and facilitate QA-related production and production-related activities

Review batch-related documentation and ensure resolution of issues to release product

Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines

Compile and verify all batch-related documents into a final product lot disposition package

Communicate lot disposition pending issues to management

Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed

Work with Manufacturing and Quality Control as a production area Quality Assurance representative. Key areas of collaboration include but are not limited to; calibration and preventive maintenance, process monitoring, and inventory control monitoring

Support site inspections and inspection readiness activities

Enhance skills via regular training and continuing education, including professional society membership/participation

Completion of gowning qualification and maintaining status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices

Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance

Perform other duties as required

Qualification

CGMP complianceQuality operationsAseptic manufacturingGCP regulationsMS Office proficiencyDocumentation PracticesOrganizational skillsInterpersonal skillsCommunication skills

Required

Minimum of a Bachelor's degree in related field and/or equivalent experience

Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards

Working knowledge of GCP, GDP, GLP and cGMP regulations and their relevant ISO counterparts and ICH Guidelines

Thorough knowledge of aseptic manufacturing processes

Excellent organizational skills, attention to detail, and Good Documentation Practices

Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications

Ability to communicate and work independently with scientific and/or technical personnel

Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management

Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities

Preferred

Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred