Senior Associate, Quality Assurance Operations
What We Do
Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state-of-the-art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.
To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.
The Senior Associate, Quality Assurance Operations will support the Quality Assurance Operations functional team that supports facility, warehouse and production operations at Theragent. The position will help support the disposition process, release of raw materials for production, labeling issuance for final drug product, and shipment of product. This position does not have supervisory responsibilities. The position requires ability to effectively communicate in oral and written form in order to present information and respond to questions from internal staff and external clients. More importantly, this role will represent the quality mindset culture we are building at Theragent. In addition, this role will assist and support deviations, change controls, CAPAs, and risk assessments to support production operations.
- Serve as Quality Operations support for Theragent production facility
- Provide QA oversight on aseptic processing and approval of deviations.
- Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelines
- Contributes to the continuous improvement of Quality Assurance programs, policies, processes, procedures, and controls ensuring compliance to regulatory agency guidelines
- Supports Quality Control with QA review and approval of materials and testing
- Maintain compliance with applicable global and local regulatory requirements
- Support and manage receipt and processing of incoming critical raw materials such as Human Cell and Tissue components
- Provide QA oversight on the packaging and shipping process; authorize shipments
- Support QA on the floor processes, including batch record review
- Review and release lot-related final product labels and documentation and ensues resolution of issues to release for manufacturing
- Supports compliance audits as required
- Understand the application of Data Integrity per 21 CFR Part 11
- Experience and familiarity with the application of FDA, GLP, QSR, and CGMP regulations
- Support continuous improvement activities
- Must be flexible to work overtime, weekends, and/or holidays to support a 5-7 day operations based on business and/or client needs
Reports to: Director of Site Quality
FLSA Status: Non-exempt
Location: Arcadia, CA
Knowledge, Skills & Abilities:
- Knowledge of cGMP, GXP, GAMP, 21CFR part 11, GDP Aseptic Processing Cell therapy experience
- Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
- Ability to effectively negotiate and build collaboration amongst individuals and peers
- Ability to motivate and inspire others to excellence
- Strong written and verbal communication skills
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi‐tasking ability in conjunction with proven organizational skills.
- Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook.
Education & Professional Experience:
- Bachelor’s degree in science related field, preferably Life Sciences or Engineering
- Minimum of 3 years of work experience in the Pharmaceutical, Life Sciences industry with CGMP
- Clean room Manufacturing and Laboratory environment
- Required to work in controlled or clean room environments
- Must be able to read, write, and converse in English
Travel: Occasional. Less than 10%
Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
- Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes
- Ability to work safely and effectively when working alone or working with others
This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.
Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.