Quality Assurance Specialitst II

Contract

Description

Job Title: Quality Assurance Specialist II

Location: Houston Headquarters Facility

Department: Quality

Reports To: Sr. Director, Quality Assurance

FLSA Status: Contract

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in need.

Gene therapy is believed to revolutionize the healthcare field in upcoming years. PackGene is well positioned to play a big role in this transformation.

Company Background

PackGene Biotech was founded in 2014 and headquartered in Guangzhou, China. It is a leading gene therapy CRO/CDMO service provider in Asia and USA.

PackGene is looking for highly motivated hands-on individuals to join our fast-growing Houston site. This is a fantastic opportunity to join a dynamic team and make a great impact.

The Quality Assurance Specialist will support manufacturing operations for our customers at the new cGMP facility in Houston TX designed to manufacture clinical stage gene therapies.

Requirements

Duties and responsibilities

· Reviews and Approves QA Records (DRs, CRs, CAPA).

· Develops, reviews, and approves GMP documents (pre and post execution).

· As assigned, conducts internal audits, QA on the floor, mater release, among other tasks.

· First point of contact for quality-related decisions during manufacturing operations.

· Leads or attends review boards for deviations, CAPAs and change requests.

· As needed, communicates and collaborates with customers in a timely manner about any quality issues or actions impacting their product.?

· Leads batch release activities.?

· Exemplify and drive a Quality Culture throughout the organization. This includes having and promoting a right-first-time mindset, respecting the procedures and policies, and striving for continuous improvement.?

· Other duties as assigned.

Skills and Qualifications

Bachelor with at least 4 years of experience in biopharmaceuticals or similar industries.

Direct experience supporting manufacturing operations.

Experience authoring, reviewing and approving GMP documents.

Experience managing deviations, CAPAs, change controls and quality metrics.

Knowledge of cGMP regulations.

Working Conditions

In Office

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 of time.

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.

Direct reports

NONE