About the job Quality Assurance Manager Quality Assurance ManagerJob DescriptionGeneral PurposeThe primary responsibility of this position is to oversight GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally. Main Job Tasks and Responsibilities Responsible for QAU administration.Torrey Pines Solutions is Hiring! We have an immediate need for a Quality Manager. Candidate must have Biotech/Pharma industry GxP experience - No exceptions. Principals only no agencies. For immediate consideration, please contact me at rwilliamson@torreypinessolutions or reviewing required documents for GMP compliance.The maintenance of the document management system.Identify training needs and organize training interventions to meet quality standardsPerform the internal/external audit and finalize the audit report Evaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicableCooperate with internal team/external parties to investigate customer complaints and non-conformance issuesAnalyze data to identify areas for improvement in the quality systemAdditional duties as required and assignedMust HaveB.S. or M.S. in sciencesPrior experience as a QA AuditorAuditing experience of GMP quality standardsAbility to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPANice-to-Have Working experience with CMO/CRO/Outsourcing Testing Lab (OTL)Drug substance/product or pharmaceutical industry-specific experienceCertifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six SigmaAuditing experience of GCP quality standardsExperience with implementation of corrective/preventive action programsKnowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines)Key Competenciesattention to detailcommunication skills - verbal and writtendata collection, management and analysisproblem analysis and problem solvingplanning and organizingjudgmentdecision-makingteamwork
Torrey Pines Solutions...Deputy Chief Operating Officer, LATAM - Senior Vice President About the Role iCapital is looking to hire a Deputy Chief Operating Officer... ...America will play a key leadership role in shaping and executing the operational strategy for the region. Based in the New York...
...our Careers page! Must be a US Citizen with a Secret or higher security clearance. This role will focus on building complex Network/System hardware and software solutions for next generation aviation products. This role requires hands-on experience with tools like...
...Publica: Porn, Piracy, Fraud: What Lurks Inside Googles Black Box Ad Empire ABC7 News: The State of Children's Privacy Online NBC News: How many apps are tracking your children Our team of lawyers, data scientists, engineers, economists and researchers span...
...Hair Stylist at Sport Clips summary: Sport Clips seeks licensed cosmetologists/hair stylists in Las Vegas/Henderson to provide haircuts and client services in a fun, team-oriented salon with paid training, continuing education, and benefits. The role emphasizes men...
...Job Description Job Description Mixing Operator 1st shift - 7:00am - 5:00pm The Mixer Operator role is focused on the mixing of 300 gal. batches of various formulations. Responsibilities: Operates an industrial mixer, vacuum pump, dust collector...