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Quality Assurance Operations Manager

Company: Theragent Inc
Location: Arcadia
Posted on: July 31, 2022

Job Description:

What We DoTheragent 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.Why Theragent?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.Our Mission:To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.Position Summary:The Quality Assurance Operations Manager leads the Quality Assurance Operations functional team that supports facility, warehouse and production operations at Theragent. The QA Manager will help manage disposition process, release of raw materials for production, labeling issuance for final drug product, and shipment of product. This position has supervisory responsibilities, which includes responsibility for hiring and developing their team. 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. This leader will have the opportunity to partner with TechOps functions from Supply Chain, Warehouse Operations, Manufacturing, Quality Control, GMP IT to ensure the successful compliant, efficient, and effective quality operations. This leader will help create a strong quality mindset culture to enable Theragent to serve clients with high quality and compliant product and processes. Primary Responsibilities:Lead and manage the Quality Operations to support client needs at Theragent production facilityProvide QA oversight on aseptic processing and approval of deviations. Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelinesMaintains Quality Assurance programs, policies, processes, procedures, and controls ensuring compliance to regulatory agency guidelinesMaintain compliance with applicable global and local regulatory requirementsSupport and manage receipt and processing of incoming critical raw materials such as Human Cell and Tissue componentsManage QA staff operations, including organizing and prioritizing group tasks, performing training, and writing performance reviewsEstablish KPIs for the group and align to enterprise goalsProvide QA oversight on the packaging and shipping process; authorize shipmentsSupport QA on the floor processes, including batch record reviewOversee lot-related final product labels and documentation and ensues resolution of issues to release for manufacturingLeads compliance audits as requiredInterfaces with contract manufacturers to address quality and compliance issuesUnderstand the application of Data Integrity per 21 CFR Part 11Experience and familiarity with the application of FDA, GLP, QSR, and CGMP regulationsLead and support continuous improvement activitiesPosition will manage a 5-7 days a week operation, which is based on business client needsReports to: Director of QualityFLSA Status: ExemptLocation: Arcadia, CAKnowledge, Skills & Abilities:Knowledge of cGMP, GXP, GAMP, 21CFR part 11, GDPAseptic ProcessingCell therapy experienceKnowledge of pharmaceutical, manufacturing, and laboratory systems and equipmentAbility to effectively negotiate and build collaboration amongst individuals and peersAbility to motivate and inspire others to excellenceStrong written and verbal communication skills in small and large group settingsStrong Organizational and Time Management SkillsExcellent interpersonal skills with experience dealing with a diverse workforceStrong 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:Bachelors degree in Science related field, preferably Life Sciences or Engineering. Minimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with CGMPMinimum 3 years of experience supervising staff in GMP production operationsWorking Conditions:Clean room Manufacturing and Laboratory environmentRequired to work in controlled or clean room environmentsMust be able to read, write, and converse in EnglishTravel: 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 periodsAbility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pullingEnvironmental Conditions: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 shoesAbility to work safely and effectively when working alone or working with othersThis 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.

Keywords: Theragent Inc, Arcadia , Quality Assurance Operations Manager, Executive , Arcadia, California

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