Quality Control Specialist II - HPLC

PackGene Biotech Co., Ltd.; Houston (TX); On-site; USD 55,000 - 90,000; Full time

Job summary

An established industry player is seeking a QC Specialist II to join their Quality Control Department. This role is pivotal in ensuring the integrity of gene therapy products through rigorous quality control testing and analytical methods. As a subject matter expert, you will utilize your hands-on experience with HPLC, qPCR, and ELISA to maintain compliance in a cGMP environment. Collaborating with cross-functional teams, you will contribute to continuous improvement initiatives while mentoring junior staff. If you are passionate about quality assurance in the biopharmaceutical industry and ready to make an impact, this is the opportunity for you.

Qualifications

• 2+ years of relevant Quality Control Laboratory experience required.
• Experience with biologics analytical release methods preferred.

Responsibilities

• Perform quality control testing on samples and finished products.
• Write/revise QC procedures and protocols as needed.
• Mentor and train junior analysts in laboratory techniques.

Skills

HPLC

qPCR

ELISA

cell-based assays

analytical lab techniques

troubleshooting

problem-solving

communication skills

Education

Bachelor's Degree

Tools

Agilent HPLC system

Vanquish HPLC system

Job description

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 is 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 industry.

General Responsibilities:

1. Perform routine and non-routine quality control testing on in-process samples and finished products using established analytical procedures and techniques.
2. Operate and maintain laboratory equipment and instruments, ensuring proper calibration and preventive maintenance.
3. Execute procedures and protocols for analytical methods in support of analytical method lifecycle activities including method transfer, qualification, validation, and compendial verification.
4. Accurately record data following respective SOPs and protocols. Report deviations and OOS’s.
5. Write/revise QC procedures, protocols and technical reports.
6. Support analytical equipment installation and operation qualification, as needed.
7. Troubleshoot assay and equipment, as needed.
8. Support quality investigations, change controls and CAPAs.
9. Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.
10. Work collaboratively with cross-functional departments including but not limited to Process Development, Quality Assurance, Manufacturing Operation, and Program Management.
11. May interact with vendors/external partners on technical matters in relation to analytical methods.
12. Mentor and train junior analysts, providing guidance on laboratory techniques, data analysis, and compliance requirements.
13. Present data and findings in internal and external meetings.
14. Assist lab supplies inventory management.
15. Work independently and in a fast-paced environment.
16. Other duties as assigned.

Skills and Qualifications

1. 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.
2. Proficient with basic analytical lab techniques including but not limited to pipetting, aseptic techniques, etc.
3. Ability to adhere to SOP’s and ensure 21 CFR Part 11 compliance.
4. Ability to adhere to timelines for testing and reporting of data.
5. Ability to function in a team-oriented environment.
6. Excellent/Effective written and verbal communications skills.
7. Strong troubleshooting and problem-solving skills.
8. Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to details.
9. Ability to work in a fast-paced, collaborative environment and manage workload based on changing priorities.
10. Demonstrated commitment to safety, quality, and continuous improvement.

Requirements

1. Specialist II: BS with 2+ years of relevant Quality Control Laboratory experience.
2. Working knowledge of cell culture, AAV and experience with GxP-based laboratory setting and regulatory guidance is a plus.
3. Strong interpersonal skills.
4. Strong problem-solving abilities and drive for success.
5. Excellent written and oral communication skills.
6. High level of self-motivation.
7. Keen attention to details.
8. 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 25 lbs 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.