Quality Assurance Specialist

Job Purpose/Summary This position will be responsible for supporting and assisting with the management and maintenance of the site-wide quality program, as well as the EHS program. The program is designed to ensure continuous measurement and improvement in site quality, compliance and overal performance. This position is responsible for overseeing key quality program elements such as, document control, internal facility audits, data and report audits, deviation, investigations, CAPA and general facility and/or study events. The employee will work to ensure the consistency, reproducibility, quality and integrity of operations in line with Crown programs. The position will employ effective tools to support risk mitigation of quality deviations and to respond to quality deviations implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulations governing the sites operations. The success of the role will be measured by continuous improvements in site quality, compliance and efficiency of operation, meeting or exceeding client expectations and corporate goals and objectives. Essential Functions/Responsibilities - Support and assist with the management and maintenance of the site-wide quality program, including GLP/GCLP/ISO9001/CLIA/CAP requirements for pre-clinical and clinical operations, as applicable. - Conduct routine internal audits of the animal vivarium, in-vitro and biomarker laboratories - Manage document control in EQMS - Assist with the site training program. - Provide support for internal/external complaint and deviation investigations. - Support study directors to develop Corrective Action Preventive Action (CAPA) plans. - Support the various site continued improvement efforts. - Lead site internal audits to ensure compliance to QMS - Support client audit and supplier qualification program. - Represent QAU on the site EHS (Environment, Health and Safety) team - Monitor site key performance indicator (KPI) and provide reports for management review - Actively contribute to the success of the overall QA team and the site as a whole. Minimum Requirements - Requires a Bachelor degree in a technical field, or equivalent combination of academic and work experience. - Requires 2 years of auditing and document control within a regulated environment - Able to interpret analytical data to support decision-making - Able to communicate in a clear, coherent and concise manner (verbal and written communication) - Willing and able to work independently and in a team environment to efficiently meet assigned timelines - Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and Internet - Excellent interpersonal, organizational and time-management skills - Able to multi-task with a high degree of professionalism and diplomacy Preferred Requirements - Laboratory working experience in regulated environment is preferred - Experience working with an EHS is team preferred - Experience with AAALAC/IACUC is preferred - Experience with Veeva Vault e-QMS and IDBS ELN systems is preferred The California salary range for this position is: $78,795.00 - $92,700.00 This salary (or salary range) is merely an estimate and may vary based on an applicant’s skills and prior relevant experience. Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Crown Bioscience, a JSR Life Sciences company, is a global contract research organization (CRO) providing discovery, preclinical, and translational platforms to advance oncology and immuno-oncology. Known for their high quality and expansive in vivo, in vitro, and ex vivo preclinical models, they partner with their clients to quantify the efficacy and pharmacological profile of their drug candidate before they move into the clinic. The company is the only preclinical CRO to provide tumor organoid services utilizing HUB technology and has the world’s largest commercially available PDX collection. Additionally, further services available in the areas of high content imaging and a 3D Ex Vivo Patient Tissue Platform, provide greater insights into complex disease pathophysiology. A range of biomarker analysis and applied genomics services are also available to optimize therapeutic benefit. Crown Bioscience helps to deliver superior drug candidates to ensure that patients get the right treatment at the right time. Founded in 2006, Crown Bioscience has 12 facilities in the US, Europe, and APAC. Find out more: www.crownbio.com Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. If you have a disability or special need that requires accommodation, please let us know: jobs@crownbio.com Headhunters and recruitment agencies may not submit resumes/CVs through this website or directly to managers. Crown Bioscience does not accept unsolicited headhunter and agency resumes. Crown Bioscience will not pay fees to any third-party agency or company that does not have a signed agreement with Crown Bioscience.

Salary : $78,795 - $92,700