Senior Quality Assurance Specialist (Contractor)
Quality | Newark, CA | Contract
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
About the role:
Allogene is seeking a highly motivated individual contributor for the role of Senior Specialist of Quality Assurance to support the Newark multiproduct manufacturing facility to ensure the quality of the site’s production by working collaboratively with manufacturing operations, facility/engineering, environmental monitoring/microbiology, and supply chain. The position will be responsible for supporting quality management system and providing direction and decision-making regarding quality operations. Must be able to work independently and professionally in the execution of production. Must be able to manage responsibilities in a fast-paced environment, meeting production objectives, while ensuring quality requirements are met. Excellent communication skills and demonstrated ability to work well with others will be essential. This role will be up to 32 hours per week.
Responsibilities include, but are not limited to:
- Review production batch record for compliance to Good Documentation Practices and established SOPs/standards
- Perform review of equipment qualification/validation Risk Assessments, Protocols/Reports and periodic reviews
- Support QMS processes including deviations, CAPAS and change controls
- Perform documentation review of media fills and media fill protocol approvals as needed
- Create / revise documents (SOPs/Forms/templates) as needed
- Write Quality procedures, policies, risk assessments, and training materials
- Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
- Other duties as assigned
Position Requirements & Experience:
- At least 5 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience.
- Bachelor’s degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred.
- Knowledge of quality systems and regulatory requirements including relevant US and EU guidelines
- Direct experience with batch review and release of viral vector and/or cell therapy product lots preferred
- Knowledge about qualifications and validation of facility/utility and computer systems is preferred
- Knowledge of systems; Blue Mountain Regulatory Asset Manager and Veeva Electronic Quality Management Systems are preferred
- Advanced computer skills with MS Office applications Word, Excel, PowerPoint, as well as Adobe Acrobat
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
- Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.