Job Description

The Quality Assurance Specialist performs a wide variety of Quality activities with minimal supervision to ensure compliance with company and regulatory requirements in support of Kolon TissueGene’s Phase III clinical trials and commercial manufacturing.

Duties and responsibilities

• Review vendor documents, including, but not limited to, batch records, work instructions, performance measures, aseptic process simulation (APS) protocols and summary reports, standard operating procedures (SOPs), quality control (QC) data, qualification/validation protocols and reports, and deviations/investigations for completeness and accuracy.
• Provide Quality oversight of vendors, including but not limited to Contract Manufacturing Organization (CMO), Contract Testing Laboratory (CTL), and Storage, Packaging/Labeling and Distribution facilities.
• Collaborate with Manufacturing and Process Development groups to resolve product and process related quality issues.
• Conduct audits to verify adherence to procedures and regulatory requirements for both internal and external systems and processes, as applicable.
• Author, revise and review internal procedures for compliance with global regulatory requirements.
• Actively participate in internal and external meetings.
• Assist in the trending of cGMP-related Quality Key Performance Indicators (KPIs) in support of the Quality Management System (QMS).
• Support internal quality systems, including deviations, change control, Corrective Action Preventive Action (CAPA), and continuous improvement.
• Assist Quality Control (QC) with equipment qualification to support Quality by Design study, as required.
• Perform on-going GXP and quality related training, as required.
• Perform data audits of CMC documentation intended for submission to regulatory health authorities (e.g., FDA, EMA).
• Provide regulatory inspection support.
• Administrative duties such as filing and organizing documentation, etc., as required.
• Other duties as assigned.

Qualifications

Bachelor of Science in biology, chemistry, engineering or related fields is required.

5+ years of GMP biopharmaceutical industry experience (preferably in Cell Therapies).

Good communication skills, interpersonal skills, ability to work in a fast paced environment.

Detail oriented, and have knowledge of scientific, medical and regulatory terms.

Ability to use personal computer and software including word processing, spreadsheet and database.

Excellent organizational and coordination skills, with close attention to detail and accuracy.

Ability to work within a team environment

Ability to build and sustain professional relationship

Ability to successfully project manage vendors with minimal supervision

Excellent problem-solving skills with minimal supervision.

Working conditions

Work is done in a private office with use of a personal computer or in meetings held in a conference room. Occasional travel is required. Some non-standard work hours e.g. evening or weekend work will be required, up to 10% travel to audit vendors, contractors, etc.

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