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Element Materials Technology
Santa Fe Springs, CA, United States
Overview Element has an opportunity for Senior Quality Assurance (QA) Specialist . In general, the duties of this position, like those of a Quality Assurance Specialist, are geared toward assisting Quality Assurance Management in administering the company’s quality system. This is accomplished through the review of laboratory technical records, pr
Job Source: Element Materials TechnologyIntegrated Resources
El Segundo, CA, United States
Job Title: Senior Quality Assurance Specialist - I Job Location: El Segundo, CA Job Duration: 6 Months (Possible extension) Pay range: $58/hr. on W2 Job Description: Client is seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with appl
Job Source: Integrated ResourcesElement Materials Technology
Santa Fe Springs, CA, United States
Senior Quality Assurance Specialist Job Locations US-CA-Santa Fe Springs ID 2024-13807 Overview Element has an opportunity for Senior Quality Assurance (QA) Specialist . In general, the duties of this position, like those of a Quality Assurance Specialist, are geared toward assisting Quality Assurance Management in administering the company
Job Source: Element Materials TechnologyActalent
Carson, CA, United States
Calling all Food Science Graduates! Hiring new grads for large Food Manufacturing company! Description: + QA documentation + Sensory Analysis + Investigational Swabs / EMP swabs + Line Coverage + Water Activity Calibration + Check Ingredients Upon Arrival + Review E-mail + Bean Puree Moisture Testing + Garbanzo Sampling Analysis Moisture
Job Source: ActalentSpecial Service for Groups, Inc- HOPICS
Los Angeles, CA, United States
Title: Quality Assurance Specialist Division: HOPICS FLSA: Non-Exempt, Full time Supervisor: Quality Assurance Manager Pay Range or Rate: $20.00-25.00 per hour Revised: 8.28.23 Summary Under the direction of the Quality Assurance Manager, the Quality Assurance Specialist is responsible for tracking, monitoring, and troubleshooting to ens
Job Source: Special Service for Groups, Inc- HOPICSIntellectt Inc
Redondo Beach, CA, United States
????????????????: Quality Assurance Specialist ????????????????????????????????: Redondo Beach, CA Duration: 06 Months (Possible for Extension) Position: 100% Onsite Job Description Assess device related complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely m
Job Source: Intellectt IncImmunityBio
, CA, United States
ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to crea
Job Source: ImmunityBioImmunityBio
Culver City, CA, United States
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer
Job Source: ImmunityBio, CA, United States
This position is onsite located in Los Angeles, CA
The Senior Specialist, Clinical Quality ensures GCP compliance with standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times.
Essential Functions
Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
Manages the incident management program through monitoring of complaints, deviations and CAPAs.
Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
Reviews the final audit documents for accuracy.
Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable.
Lead development and implementation efforts for inspection readiness at all times.
Assists senior staff during regulatory inspections or other audits.
Represents QA department at internal and external meetings supporting clinical programs.
Performs other Quality related duties, as assigned.
Education & Experience
Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master’s degree in a life sciences or engineering discipline with a minimum of 4 years’ of experience in a GCP-Biologics or Pharmaceutical environment.
CQA or other audit certifications are a plus.
Prior TMF or electronic document management systems experience is a plus.
Demonstrated understanding and application of ICH GCP E6 (R2)12
25%-30% travel may be required
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Email Alert for Senior Quality Assurance Specialist jobs in , CA, United States
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