Senior Quality Assurance Specialist

4 days ago

Thousand Oaks, United States Aditi Consulting Full time
Payrate: $35 - $37/hr.

Specific responsibilities include but are not limited to:
  • Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across company Operations and R&D, to the Digital QMS platform for health and control processes.
  • Leads Digital QMS audit & inspection readiness, deviations and change control activities
  • Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
  • Manages and provides oversight of documents / records within the Quality Management System
  • Oversight of process key performance indicators and metrics
  • Manages external contractors providing services to the Digital QMS
  • Working across teams managing priorities

Preferred Qualifications:
  • Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
  • Ability to converse technically with mechanical, electronic, software, and quality engineers Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304)
  • Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
  • Experience with risk-based Supplier Quality Management process.
  • Management of Global Inspection and Audit programs
  • Proficient working on multiple projects in a deadline driven environment
  • Strong decision making and organization skills with the ability to prioritize multiple business priorities.
  • Experience in project management, process improvement and quality system management
  • Effective verbal and written communication skills (writing and presentations) in English

Top 3 Must Have Skill Sets:
  • Experience in supplier quality management
  • Audit and inspection management
  • Ability to work across multiple groups and stakeholders- experience with strong collaboration

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

#AditiConsulting

  • Senior Quality Assurance Associate

    6 hours ago

    Thousand Oaks, United States Randstad Life Sciences US Full time

    Job Details:Senior Associate Quality Assurance in Thousands Oak, CA3 Years ContractMust be flexible as it is possible worker will start on any shift. Rotate every 6 months.DAY 7 AM - 8 PMSWING 1 PM to MidnightNIGHT SHIFT 7 PM - 8 AMWill change on the business they are supportingRotate every 6 monthsJob Summary:This position supports Company’s Quality...

  • Global Quality Assurance Specialist for Biotechnology Operations

    2 weeks ago

    Thousand Oaks, California, United States ApTask Full time

    About ApTaskApTask is a leading provider of workforce solutions and talent acquisition services. Our mission is to empower organizations to thrive while fostering a diverse and inclusive work environment.Job OverviewWe are seeking a highly skilled Global Quality Assurance Senior Specialist to coordinate global incoming quality process operations and support...

  • Quality Assurance Specialist

    2 weeks ago

    Thousand Oaks, California, United States Randstad Full time

    Job SummaryWe are seeking a skilled Quality Assurance Specialist to join our team at Randstad. In this role, you will be responsible for performing quality control operations, including inspection and disposition of raw materials, revising documents to maintain compliance, and initiating supplier investigations.This is a 12-month contract position with the...

  • Quality Assurance Associate

    6 hours ago

    Thousand Oaks, United States ApTask Full time

    Position Details:Job Title: Senior Associate Quality AssuranceLocation: Thousand Oaks, CA Onsite Duration: 12 Months contract with possibility of extensionJob SummaryThis position supports Client’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the...

  • MCS Senior Associate Quality Assurance

    5 days ago

    Thousand Oaks, United States Volt Full time

    Innova Solutions has a client that is immediately hiring for MCS Senior Associate Quality Assurance Position type: Full-time ContractDuration: 36 months ContractLocation:  Thousand Oaks, CA As a MCS Senior Associate Quality Assurance, you will: Must be flexible as it is possible worker will start on any shift. Rotate every 6 months.DAY 7 AM - 8 PMSWING...

  • Quality Assurance Senior Specialist

    2 weeks ago

    Thousand Oaks, United States ApTask Full time

    About Client: The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience. It has developed a wide range of biologic...

  • Sr. Associate, Quality Assurance

    6 hours ago

    Thousand Oaks, United States Randstad Life Sciences US Full time

    Immediate opportunity for a Senior Quality Assurance (QA) Associate to support the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas.Position Type: 3 year contract (through January 2028)Schedule/Shift: 40 hrs./week, 8 hrs./day; will rotate shifts based on the business supported....

  • MCS Senior Associate Quality Assurance

    3 days ago

    Thousand Oaks, United States Advanced Bio-Logic Solutions Corp Full time

    Job DescriptionJob DescriptionDescription:Note:FULLY ONSITE AT USTOMust be flexible as it is possible worker will start on any shift. Rotate every 6 months.DAY 7 AM - 8 PMSWING 1 PM to MidnightNIGHT SHIFT 7 PM - 8 AMWill change on the business they are supportingRotate every 6 months Quality Assurance program under the Plant QA organization providing daily...

  • MCS Senior Associate Quality Assurance

    25 minutes ago

    Thousand Oaks, United States Aditi Consulting Full time

    Pay Rate: $28.00 - $32.00/hr. Summary: This position supports client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their...

  • Quality Assurance Specialist

    4 weeks ago

    Thousand Oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • Quality Assurance Specialist

    1 month ago

    Thousand Oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • Quality Assurance Specialist

    4 weeks ago

    thousand oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • MCS Senior Associate Quality Management

    11 hours ago

    Thousand Oaks, California, United States Volt Full time

    About the JobInnova Solutions has an exciting opportunity for a MCS Senior Associate Quality Management to join their team in Thousand Oaks, CA.Job DescriptionThis role will support the Quality Assurance program under the Plant QA organization, providing daily oversight of Drug Substance manufacturing areas. The successful candidate will ensure compliance...

  • Director, Quality Assurance

    4 weeks ago

    Thousand Oaks, United States VetJobs Full time

    Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set,...

  • Quality Assurance Specialist

    2 weeks ago

    Thousand Oaks, California, United States ApTask Full time

    About Client:The client is a leading biotechnology company focusing on human therapeutics development and manufacturing.It has developed a wide range of biologic medicines, including biotechnology drugs and innovative therapies.The company collaborates with academic institutions and biotechnology partners to advance its research efforts.Estimated Salary:...

  • Global Quality Assurance Manager for Pharmacovigilance and Clinical Research

    2 weeks ago

    Thousand Oaks, California, United States Lifelancer Full time

    Amgen is dedicated to improving the quality of life for people around the world by developing treatments that take care of others. As a Global Quality Assurance Manager for Pharmacovigilance and Clinical Research, you will play a critical role in ensuring the quality and integrity of our products.About the RoleThis position requires a strong background in...

  • Reliable Quality Assurance Engineer for Regulated Medical Devices

    2 weeks ago

    Thousand Oaks, California, United States Planet Pharma Full time

    Job SummaryWe are seeking an experienced Sustaining Engineer to join our team at Planet Pharma. As a key member of our Engineering department, you will be responsible for ensuring the quality and integrity of our medical devices throughout their lifecycle.About the RoleThis is a 12-month contract position with opportunities to extend or convert to a...

  • Engineer Senior

    2 weeks ago

    Thousand Oaks, United States Belcan Full time

    Engineer Senior Job Number: 351028 Category: Manufacturing Engineering Description: Job Title: Senior Engineer Job Type: 12 months of contract Location: Thousand Oaks, CA ZIP Code: 91320 Pay Rate: up to $48/hr. Start Date: Right Away Keywords: #Engineer #SeniorEngineer Responsibilities: This engineering position supports manufacturing activities...

  • Engineer Senior

    1 week ago

    Thousand Oaks, United States Belcan Corporation Full time

    Job Details Manufacturing Engineering Job Title: Senior Engineer Job Type: 12 months of contract Location: Thousand Oaks, CA ZIP Code: 91320 Pay Rate: up to $48/hr. Start Date: Right Away Keywords: Engineer SeniorEngineer Responsibilities: This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Client...

  • Senior Regulatory Affairs Specialist

    16 hours ago

    Thousand Oaks, United States Lifelancer Full time

    Job Title: Senior Regulatory Affairs Specialist (USA - Remote)Job Location: Thousand Oaks, CA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelEmployer Industry: Medical Device ManufacturingWhy Consider This Job Opportunity Salary up to $125,100 Potential for annual performance bonus and comprehensive...