Quality Control Specialist II - HPLC

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.

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 communication and making fine discriminations in sound.
• Kneeling: Bending legs at knee to come to a rest on knee or knees.
• Lifting: Raising objects of 25lbs from a lower to a higher position or moving objects horizontally from position to position. This factor is important if it occurs to a considerable degree and requires the substantial use of the upper extremities and back muscles.
• Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.
• Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.
• Reaching: Extending hand(s) and arm(s) in any direction.
• Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Sitting: Sitting for a period.
• Standing: Remaining upright on the feet, particularly for sustained periods of time. ?????
• Stooping: Bending body downward and forward by bending spine at the waist.
• Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.?
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at?distances close to the eyes.