Quality Control Specialist II - HPLC

Description

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish and QC analytical services for the gene therapy industry.

Company Background

Packgene Biotech was founded in 2014 and headquartered in Guangzhou China. It provides CRO/CDMO services to the emerging gene therapy industry and research institutes. PackGene Biotech (US) is a full subsidiary of the parent company and is expanding its global footprint to Houston TX.

Overview

 The Quality Control Department at PackGene Biotech is seeking a talented individual for the role of QC Specialist II. The QC Specialist II will be a subject matter expert with troubleshooting and training skills. At its core, the position requires a strong working knowledge and experience with QC Analytical Assays and its applications within a cGMP production facility. The Specialist II/ will have experience with biologics analytical release methods and requirements common to the biopharmaceutical industr  

General Responsibilities:

Perform routine and non-routine quality control testing on in-process samples and finished products using established analytical procedures and techniques.

· Operate and maintain laboratory equipment and instruments, ensuring proper calibration and preventive maintenance.

· Execute procedures and protocols for analytical methods in support of analytical method lifecycle activities including method transfer, qualification, validation, and compendial verification.

· Accurately record data following respective SOPs and protocols. Report deviations and OOS’s.

· Write/revise QC procedures, protocols and technical reports.

· Support analytical equipment installation and operation qualification, as needed.

· Troubleshoot assay and equipment, as needed

· Support quality investigations, change controls and CAPAs.

· Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.

· Work collaboratively with cross functional departments including but not limited to Process Development, Quality Assurance, Manufacturing Operation, and Program Management.

· May interact with vendors / external partners on technical matters in relation to analytical methods.

· Mentor and train junior analysts, providing guidance on laboratory techniques, data analysis, and compliance requirements.

· Present data and findings in internal and external meetings.

· Assist lab supplies inventory management.

· Work independently and in a fast-paced environment.

· Other duties as assigned

Skills and Qualifications

· Hands on experience in assays based on HPLC, qPCR, ELISA, and/or cell-based assays. Having direct experience with the Agilent HPLC system, and / or the Vanquish HPLC system is a plus.

· Proficient with basic analytical lab techniques including but not limited to pipetting, aseptic techniques, etc.

· Ability to adhere to SOP’s and ensure 21 CFR Part 11 compliance.

· Ability to adhere to timelines for testing and reporting of data.

· Ability to function in a team-oriented environment.

· Excellent/Effective written and verbal communications skills

· Strong troubleshooting and problem-solving skills.

· Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to details.

· Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities.

· Demonstrated commitment to safety, quality, and continuous improvement.

Requirements

Qualifications

• Specialist II: BS with 2+ years of relevant Quality Control Laboratory experience.
• Working knowledge of cell culture, AAV and experience with GxP-based laboratory setting and regulatory guidance is a plus.
• Strong Interpersonal skills.
• Strong problem-solving abilities and drive for success.
• Excellent written and oral communication skills. 
• High level of self-motivation. 
• Keen attention to details. 
• Extensive experience working in a team-oriented, collaborative environment. 

Working conditions

• In laboratory  

Physical requirements

• Crouching: Bending the body downward and forward by bending leg and spine. 
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communi