Pharmaceutical - Quality Assurance
1 day ago
Job Description: The individual in this position is responsible for performing day-to-day quality assurance (QA) activities, managing QA processes such as document management, internal audits, instrumentation change control, corrective and preventative actions, and assay validation planning to ensure compliance to GCLP requirements as the Client Oncology Clinical Research Laboratory (POCRL) develops, validates, and performs clinical trial assays. In addition, the position is responsible for providing QA support for clinical trial assay activities, including receipt, accessioning, and internal tracking of clinical trial biospecimens. RESPONSIBILITIES: Maintain, troubleshoot, and monitor the effectiveness of the POCRL's Quality Management System (QMS) Ensure that POCRL activities conform with the requirements of the laboratory QMS Coordinate creation, approval, implementation, and periodic reviews of Client Standard Operating Procedures for the POCRL according to GCLP guidelines Review and approve new assay validation plans and reports according to GCLP guidelines with reference to CAP/CLIA regulations for molecular assay validation Draft, review and approve continuing quality improvement documentation Maintain laboratory QMS documentation in Client's document management system Conduct annual QA audits of the POCRL & clinical trial assay processes, document findings, compose and execute Corrective and Preventative Action Plans as appropriate Coordinate external QA audits as required and advise laboratory director of appropriate corrective actions Serve as the POCRL's point of contact with clinical Biomarker Assay Specialist groups within early- and late-clinical development Ensure that the maintenance/calibration status of POCRL equipment is monitored and current TECHNICAL SKILLS: Ability to create and enforce laboratory standard operating procedures Knowledge of molecular biology and laboratory safety procedures for handling hazardous chemicals and biosafety level 2 biohazard materials Knowledge of standard molecular biology laboratory equipment Excellent written and verbal communication skills Ability to work independently Ability to interface with clinical research teams Proficiency with standard office software (Microsoft Office, Adobe Acrobat) Minimum Education Experience Required: BS/MS in a biological science, pharmacy, medical technology, or a related field Medical Technology, MT (ASCP) license or equivalent (preferred) At least 2 years' experience working in a laboratory setting that included a QMS Good working knowledge of GCP/GCLP guidelines Experience working in a GCP/GCLP environment (preferred) Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr
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San Francisco, California, United States Pliantrx Full timeWe are seeking a highly experienced and skilled Quality Assurance Director to lead our pharmaceutical development team at Pliant Therapeutics. As a subject matter expert in cGMP regulations, you will be responsible for ensuring compliance with regulatory standards, industry best-practices, and internal procedures.About the RoleThis hybrid position requires 3...
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Quality Assurance Specialist
4 days ago
San Diego, California, United States Planet Pharma Full timeJob Title: Quality Assurance SpecialistAbout Planet Pharma:We are a leading pharmaceutical company dedicated to delivering high-quality products and services.Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for scanning and routing invoices for coding and approval,...
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San Francisco, California, United States B. Braun Medical Inc Full timeOverview of the RoleThe Quality Assurance Specialist for Pharmaceutical Stability will be responsible for designing, executing, and coordinating stability programs to meet annual commercial stability commitments. This role requires collaboration with various departments, including Quality Control, Research and Development, and Regulatory Affairs.Main...
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San Diego, United States Kumquat Biosciences Inc. Full timeDescriptionKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having...
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San Diego, United States Kumquat Biosciences Inc Full timeDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having...
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Sr. Specialist Quality Assurance
1 month ago
san diego, United States Proclinical Staffing Full timeSr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...
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Sr. Specialist Quality Assurance
1 month ago
san diego, United States Proclinical Staffing Full timeSr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...
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Sr. Specialist Quality Assurance
1 month ago
San Diego, United States Proclinical Staffing Full timeSr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...
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Senior Quality Assurance Specialist
6 days ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob OverviewBecton, Dickinson and Company (BD) is a leading global medical technology company that seeks a skilled Senior Quality Systems Engineer to join our team. As a Sr. Quality Systems Engineer, you will play a crucial role in planning and implementing corrective actions (CAPA) to address quality issues, developing and managing quality systems to ensure...
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Quality Assurance Expert
4 days ago
San Diego, California, United States Booz Allen Hamilton Full timeJob Summary:The Quality Assurance Specialist will work with engineering, operations, support services, cybersecurity, and program management team members to evaluate developed systems for the organization. The specialist will review, develop, and implement documentation based on requirements of processes, products, and deliverables.Responsibilities:Review...
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San Diego, California, United States Arthrosi Therapeutics Inc Full timeOverviewArthrosi Therapeutics Inc is a biopharmaceutical company advancing a best-in-class drug candidate for the treatment of gout and tophaceous gout. We are seeking a highly experienced leader to join our team as Senior Director of Pharmaceutical Development.About the RoleThe Senior Director of Pharmaceutical Development will lead and oversee all aspects...
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Quality Assurance Specialist
6 days ago
San Diego, California, United States MILLENNIUMSOFT Full timeJob Title: Quality Assurance SpecialistAt MillenniumSoft, we are seeking a Quality Assurance Specialist to support new product development and sustaining activities. The ideal candidate will have a strong background in quality engineering, with experience in ISO 9001 and ISO 13485 environments. Key responsibilities include reviewing and assessing Quality...
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Quality Assurance Lead
2 days ago
San Francisco, California, United States Annexon Biosciences Full timeAbout UsAt Annexon Biosciences, we're a biopharmaceutical company pioneering novel therapies for patients with classical complement-mediated neuroinflammatory diseases. Our mission is to advance groundbreaking treatments that make a meaningful impact on people's lives.The RoleWe're seeking an exceptional Quality Assurance Lead to spearhead our clinical...
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Quality Assurance Specialist
1 week ago
San Diego, United States Booz Allen Hamilton Full timeJob Number: R0208499Quality Assurance SpecialistThe Opportunity:As the quality assurance expert, you‘ll work with engineering, operations, support services, cybersecurity, and program management team members that evaluate developed systems for the organization. You‘ll review, develop, and implement documentation based on requirements of processes,...
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Quality Assurance Technician
2 weeks ago
San Diego, United States Sol-ti Full timeCareer BasicsLocation: San Diego, CAIndustry Type: ManufacturerCategory: SalesBeverages: SuperFood Beverages, Wellness ShotsEmployment Type: Full-TimeReports to: Wes Baldwin# of Direct Reports: 0For this position, candidate must reside in Tri-state New York area and be seeking a full-time position.Position SummarySol-ti is in search of an individual who will...
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Quality Assurance Analyst
2 months ago
San Diego, United States Johnson Service Group Full timeJohnson Service Group, is looking to hire a Quality Assurance Analyst for a privately held commercial medical device company in San Diego.This role is Direct Hire | Onsite | The salary range for this position is between$75K - $100K, based on experience. Essential Functions: Assist with quality system supplier audits as required. Author, review and approve...
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Sr. Specialist Quality Assurance
4 weeks ago
San Diego, CA, United States Proclinical Staffing Full timeSr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...
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Quality Assurance Specialist
5 days ago
San Francisco, California, United States Planet Pharma Full timePlanet Pharma is seeking a Quality Assurance SpecialistThe estimated salary range for this position is $35 - $43.33 per hour, based on experience.This role is 100% onsite in South San Francisco, California, and candidates must be local.This is a 10-month contract position, with the possibility of extension based on workload.The working hours are 8am - 5pm,...
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RCM Quality Assurance
1 day ago
San Diego, United States Remitz, Inc Full timeRemitz is a forward-thinking company at the forefront of revolutionizing the $250B Revenue Cycle Management Industry. Specializing in medical billing software, we deploy breakthrough AI and cutting-edge technology to modernize the world of medical insurance claims. Our innovative solutions are meticulously designed to enhance efficiency, accuracy, and...
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Head of Quality Assurance Management
7 days ago
San Diego, California, United States Redeployment Full timeJob SummaryWe are seeking an experienced Head of Quality Assurance Management to lead the quality management function at our innovative biotechnology company in San Diego, CA. As a key member of the leadership team, you will be responsible for overseeing quality assurance across all GxP activities, vendor qualifications, and audits.