Cell Therapy Quality Assurance Specialist

OrganaBio•San Diego, CA

22h•$32 - $37•Onsite

About The Position

The Cell Therapy QA Specialist is responsible for supporting the production of various cellular products in a clean room manufacturing environment. The Specialist will be responsible for working in cGMP ISO7 and ISO8 manufacturing spaces and controlled, supportive laboratory and warehouse areas. The Specialist will be responsible for QA support including, but not limited to, on the floor QA support, document management, support disposition of raw materials and product, deviation/CAPA/change control approvals as well as oversight of material and product storage and distribution.

Requirements

Degree in biology or related field or equivalent combination of education, training and/or experience.
5+ years industry experience with in a GMP Quality or Manufacturing environment.
Must have an understanding of adherent cell culture processes.
Aseptic technique, cleanroom gowning, and extensive knowledge of Good Manufacturing Practices (GMPs).
Understanding of how to apply FDA, EMA and other regions in a GMP manufacturing environment.
Experience with drafting and revising controlled documents.
Experience in deviations, CAPA, and change control.
Ability to perform calculations including cell concentration determination, seeding densities, % viability, weight measurements, and volume.
Ability to identify potential equipment or process issues.
Ability to organize information for multiple, concurrent projects.
Interpersonal skills to establish and maintain professional relationships both internally and externally.
Works collaboratively with internal and external cross-functional teams.
Critical thinking, creativity, and innovative thinking.
Detail oriented with the ability to set priorities and organize daily work requirements.
Must be able to work both as a team member and independently, as required.
Proficient in professional communication both written and oral, which is clear and precise.
Must keep management informed on any compliance and/or operational issues that arise.
Must be flexible, as production priorities, timelines, and processes can change regularly.
Integrity and discretion – ability to maintain confidentiality.
Ability to perform under pressure.

Nice To Haves

Cell culture and aseptic processing experience preferred.
Biotech certificate valued, not required.

Responsibilities

Adheres to, and trains team members on good manufacturing practices (GMP) guidelines.
Provides on the floor support to manufacturing team members - understands manufacturing steps per BPR and recognizes when deviations or incidents are to be documented.
Ensure aseptic processing techniques and appropriate cleanroom behavior are followed.
Perform room and line clearances in support of manufacturing schedule.
Must clothe in clean room gowns to work in a clean room environment.
Supports environmental monitoring processes defined by the facility and assists with troubleshooting.
Have experience in writing and/or revising Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and other Quality/Compliance related documents.
Review completed batch records for GMP compliance and completeness, compile information for disposition.
Preparation for and management of client audits and regulatory inspections.
Participate in corrective and preventive action teams, assist with investigation, and root cause analysis and verify that actions are implemented and effective.
Escalate issues to management and troubleshoot and develop solutions.
Maintains client confidentiality as required.
Assist Subject Matter Expert (SME) with providing training for new and existing employees.
Supports and participates in research and investigational studies, as needed.
Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.
Works collaboratively with internal and external cross-functional teams.
Supports the Excellos Labs safety, GMP and Quality Plan.
Participates in department meetings and educational programs.
Performs other duties as assigned.