QC Specialist
Asahi Kasei Semiconductor, Inc.
The Woodlands, TX
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company:
Bionova Scientific LLC Job Description: The QC lab at Bionova, an Asahi Kasei company, in The Woodlands, TX, is seeking a self- motivated and innovative candidate with strong technical communication skills. If you are a QC Specialist with 8+ years of work experience, team player mindset, and expertise in analytical testing of biologics to contribute to our expanding business, please apply. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes. Location: The Woodlands, TX Onsite Essential Duties and Responsibilities:
Bionova Scientific LLC Job Description: The QC lab at Bionova, an Asahi Kasei company, in The Woodlands, TX, is seeking a self- motivated and innovative candidate with strong technical communication skills. If you are a QC Specialist with 8+ years of work experience, team player mindset, and expertise in analytical testing of biologics to contribute to our expanding business, please apply. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes. Location: The Woodlands, TX Onsite Essential Duties and Responsibilities:
- Support establishment of Plasmid DNA QC laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols.
- Assist in implementing GMP procedures, processes, and systems within the Quality Control (QC) team.
- Provide training to QC personnel on instrumentation, techniques, and analytical chemistry methods as needed.
- Participate/lead in the development, transfer, and validation of instrument and analytical test methods across various platforms including analytical test methods HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing, wet chemistry and others as required.
- Support/lead stability studies program by generating protocols and reports and other tasks as required.
- Contribute/ author technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents as required by project specifications.
- Lead or oversee method transfer and qualification of analytical test methods (HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing and others) as required.
- Lead/coordinate/support of internal and external projects related to analytical/Micro/EM.
- Support/evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities.
- Participate/support internal and external audits.
- Initiate and investigate deviations, implement Change Control procedures, and manage CAPA activities.
- Revise/initiate general QC Standard Operating Procedures (SOPs), test methods, and test method forms as required.
- Conduct analytical testing for method qualification/validation/transfer, raw materials, in-process stages, lot release, and stability samples
- Analyze and interpret analytical data to support various initiatives, making recommendations for process improvements.
- Maintain laboratory equipment according to established procedures.
- Assist in investigating issues and non-conformities related to products and projects, including troubleshooting equipment and testing procedures to identify root causes of issues and participate in laboratory investigations.
- Support multi-compendial harmonization efforts (USP, EP, JP) for raw material, in-process, product release, and stability testing.
- Contribute to maintaining the QC lab in a clean, organized, and compliant manner at all times.
- Perform any other QC-related tasks as required.
- Interpret/review analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.
- This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
- Initially, remote working conditions transitioning to long term permanent, onsite position; occasional travel.
- Bachelor's Degree or above from an accredited institution in Chemistry, or Biology (or closely related degree).
- Requires 8+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics.
- In-depth understanding of analytical and microbial test methods and industry-standard analytical tools (HPLC/UPLC, sequencing, PCR, ELISA, microbiological assays, compendial assays, etc.).
- Experience with new laboratory start-up and equipment commissioning.
- Hands-on experience in running, qualifying, and validating analytical methods.
- Creative thinker that can identify and efficiently improve methods to address issues and gaps.
- Demonstrate ability to work independently and on cross-functional teams.
- Proven client interactions and project management experience desired.
- Strong attention to detail.
- Effective verbal and written communication skills.
Posted 2026-08-04
Recommended Jobs
Beauty and Wellness Consultant
Walgreens
Grapevine, TX
Job Objectives Maximizes sales and brand awareness by providing exceptional customer care to all customers in a friendly, efficient, and professional manner; gives impartial, personalized, experti…
View Details
Posted 2026-07-30
Patient Transporter
University of Texas Health Science Center at San Antonio
San Antonio, TX
Under limited supervision, responsible for providing a variety of activities related to the transportation of patients, guests, and equipment. Actively engages patient population in the waiting room …
View Details
Posted 2026-08-03
Physician Support
Bravo Quality Supply LLC
Houston, TX
This position is at Bravo Quality Supply LLC The selection process will be fully managed by Bravo Quality Supply LLC. This opportunity is available in New York City, Los Angeles, Chicago, Houst…
View Details
Posted 2026-08-03
Digital Campaign Strategist
Houston Methodist
Houston, TX
At Houston Methodist, the Digital Campaign Strategist position is responsible for leading, managing and partnering with digital marketing management, marketing business partners and creative teams in …
View Details
Posted 2026-08-03
Server
Emerald.Tavern Games
Austin, TX
Summary Provide friendly, responsive service to create an exceptional dining experience for all our guests. Each server’s primary objective is to treat guests like guests in their own home, ensuring…
View Details
Posted 2026-05-27
Clerk Data Control 2
CPS Energy
San Antonio, TX
: We are engineers, high line workers, power plant managers, accountants, electricians, project coordinators, risk analysts, customer service operators, community representatives, safety and securit…
View Details
Posted 2026-07-31
Asphalt Laborer
Overland Corporation
Texas
Asphalt Laborer (Entry-Level) Start Your Career. Build the Road. Grow with Overland. Overland Corporation is a leading heavy civil construction company based in Ardmore, OK, with a strong reputati…
View Details
Posted 2026-07-04
Field Supervisor Home Care
AccentCare, Inc.
Corpus Christi, TX
Job Description Job Description Location: Corpus Christi Position: Field Supervisor Job ID: 75952 Remote/Virtual Position : No Coverage Area: Corpus Christi and surrounding ar…
View Details
Posted 2026-07-17