Assists and supports the organization with initial compliance monitoring of conformance to established quality assurance processes and standards for manufacturing and production of cell therapy products. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures.**KEY ROLES/RESPONSIBILITIES (QA Specialist)**The QA Specialist:- Reviews batch records and test results for completeness, accuracy and conformance to specifications- Reviews and releases raw materials for conformance to specifications- Performs in-process audits of manufacturing, analytical, and other activities- Performs area clearance activities- Develop QMS system and procedures- Assists with Quality Management System process audits- Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions.- Assists in the identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.)- Assists with audits from regulatory bodies and external customers- Contributes to process improvement projects- Assists others in writing SOPs and other documents- Contributes to quality training development- Prepares supporting documentation for release of products- Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)- Supports management in the implementation of the Quality Management System- Reviews and releases raw materials for conformance to specifications- Performs in-process audits of manufacturing, analytical, and other activities- Performs line clearance for area clearance activities- Assists with Quality Management System process audits- Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions- all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)- Supports management in the collection and trending of Key Performance Indicators (KPIs) and trending- Participates in team and project meetings**BASIC QUALIFICATIONS**- Bachelor's or Master degree for an accredited college or university from an accredited college or university- In addition to the education requirement:- Quality Specialist : Minimum of 2 to 5 years related experience in quality assurance experience in a GMP regulated environment.**PREFERRED QUALIFICATIONS**- Experience in a Phase I/II/III clinical trial, GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products- Experience with Quality System Management- Demonstrated problem solving skills- Ability to work in a team environment with mínimal supervision to complete responsibilities- Ability to communicate ideas clearly and effectively with all levels**Salary**: RM3,000.00 - RM4,000.00 per monthSchedule:- Monday to FridayAbility to commute/relocate:- Kuala Lumpur: Reliably commute or planning to relocate before starting work (required)Expected Start Date: 01/01/2024
