Quality Control Associate I
- Employer
- iBio, Inc.
- Location
- Bryan, TX
- Start date
- Jul 21, 2022
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Lone Star Bio
At iBio, we’re growing tomorrow’s biologics with our FastPharming® System for high-quality, eco-friendly production of recombinant proteins using plants. At our 130,000 square foot manufacturing facility and headquarters in Bryan, Texas, we combine vertical farming, automated hydroponics, and molecular biology to produce therapeutics, vaccines and products for life science research and bioprocessing. We’re putting these capabilities to work for our clients via our array of contract development and manufacturing services, as well as deploying them for the advancement of our own pipeline of therapeutics, vaccines, and products for research & bioprocessing applications. We’ve recently expanded our footprint to San Diego where our early-stage drug discovery team is pioneering the next generation of biopharmaceuticals for the treatment of cancers, as well as fibrotic and infectious diseases.
Just imagine what we can do together! We know extraordinary things happen when individual talent, technology, and a great mission cross paths: the opportunity to create an outstanding team and a world-class company. We are looking to hire exceptional people who have demonstrated track records of success to continue to build a leading biotechnology and development services organization.
Apply now for our Quality Control Associate I position and help bring the power of plants to the biopharmaceutical industry!
MISSION OF THE POSITION
The QC Associate 1 is responsible for analysis supporting: (1) environmental monitoring (purified water and ISO clean rooms), (2) raw material release supporting GMP manufacturing, (3) in-process GMP manufacturing control samples, (4) finished product (drug substance, drug product, microbial cell banking, related products) and (5) additional analysis required to support the operational goals of the business.
In addition to analysis, the QC Associate 1 is responsible for sample acquisition, reporting data compliant to cGMP standards (i.e., Good Documentation Practices (GDP), analytical investigations (OOS investigation management), compliance to standard laboratory safety practices, and general GMP laboratory practices including reagent labeling and verification of instruments prior to use.
WORK LOCATION
The Quality Control Associate I position is located in Bryan, Texas.
ESSENTIAL DUTIES & RESPONSIBILITES
- Sample test sites, complete analysis, and report results in accordance with standard operating procedures.
- Perform routine environmental monitoring testing – testing specific to ISO clean rooms and United States Pharmacopeia (USP) for purified water.
- Prepare reagents and associated test solutions in accordance with standard operating procedures.
- Participate in chain of custody of samples/materials delivered to Quality Control .
- Revise documents, including SOP’s and protocols as necessary.
- Complete data entry to support tracking and trending – statistical process and statistical quality control.
- Escalate out-of-specification OOS and out-of-trend (OOT) results to Quality Management.
- Participate in QC laboratory inventory control.
- Provide support to audit teams for internal inspections as required.
Requirements
KNOWLEDGE, SKILLS, & ABILITIES
- Interpersonal, teamwork, organizational, and workload planning skills are required.
- General familiarity with the United States Pharmacopeia (USP), GMPs via the U.S. FDA, and ISO standards (e.g., testing and calibration laboratories)
- Proficient in Microsoft Office Suite
- Must be capable of using a computer and learning various user interfaces associated with analytical software packages.
EDUCATION & EXPERIENCE
- Bachelor’s degree (B.A./B.S.) in scientific discipline/field.
- Preference for certifications applicable to quality control and/or cGMP industry.
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at Phone: 979-446-0266 Email: bridget.mapes@ibioinc.com
Equal Opportunity Employer, including disabled and veterans.
If you want to view the EEO is the Law poster, please choose your language: English – Spanish – Arabic - Chinese
If you want to view the EEO is the Law Supplement poster, please choose your language: English – Spanish – Chinese
If you want to view the Pay Transparency Policy Statement, please click the link: English
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert