Total Quality Senior Specialist jobs in San Francisco, CA

Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)

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Senior Quality Systems Specialist
  • Cellares
  • South San Francisco, CA FULL_TIME
  • Position Summary


    We are seeking an innovative and highly motivated individual to join us as the Senior Quality Systems Specialist at our facility located in South San Francisco, CA. You will be responsible for maintaining the Quality System within the requirements of FDA’s GMP regulations.


    The primary focus of this position will be to manage the day to day activities of the eQMS including document control, training, supplier quality management and change control.


    This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. This role will be a hands-on resource and will be required to be on-site (with certain instances where work-from-home is permitted).


    Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. 


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    Responsibilities
    • Responsible for administrative controls, system configurations, periodic system upgrades and continuous improvement efforts of the eQMS, as needed
    • Maintain and improve quality system procedures and programs including training programs, document control, data integrity, supplier quality management and change control
    • Manage the periodic review program of the eQMS
    • Coordinate employee training; including, employee onboarding to the QMS, daily training tasks within the eQMS, training plans, and training content, etc.
    • Coordinate document control processes within the eQMS, including reviewing document formatting, periodic reviews of documents, training authors and approvers to use the system, etc.
    • Coordinate supplier qualification efforts for assigned suppliers; including, driving the processes within the eQMS such as requesting and reviewing supplier questionnaires, performing supplier risk management, periodic review of suppliers, supplier audits, supplier corrective actions (SCARS), etc.
    • Coordinate change control processes, routing change requests for evaluation, following up on open change controls, hosting change control review board meetings, etc.
    • Support internal and external audits and client inspections, as needed
    • Develop quality system metrics for training program, document control, supplier quality and change control to track compliance, productivity and effectiveness to be presented during the Quality Management Review
    • Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System.


    Requirements
    • Bachelor's degree or higher in a relevant scientific discipline - Biotechnology, Biology, Biochemistry, or Chemistry
    • 5 years experience in a GMP environment
    • Strong technical knowledge of cGMP regulations and eQMS systems
    • Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211, TrackWise Digital experience preferred
    • Strong understanding of regulatory inspection and knowledge of their requirements
    • Ability to build strong working relationships with cross-functional departments
    • Excellent interpersonal, verbal, and written communication skills
    • Comfortability in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
    • Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset


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    $90,000 - $210,000 a year
    Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
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    This is Cellares


    Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

    The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.


    Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.


  • 3 Days Ago

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Senior Quality Specialist
  • Bausch Health
  • San Francisco, CA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 14 Days Ago

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Senior Manager of Total Rewards
  • Business Wire
  • San Francisco, CA FULL_TIME
  • Business Wire, a Berkshire Hathaway company, is the global market leader in press release distribution and regulatory disclosure. We are on a mission to redefine how organizations connect with their a...
  • 13 Days Ago

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Quality Inspector II
  • Total Aerospace Services
  • San Francisco, CA FULL_TIME
  • Do you want to be a part of a team of aviation innovators who are helping change the industry landscape? Our client is the leading and most comprehensive provider of maintenance, repair, and overhaul ...
  • 25 Days Ago

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Quality specialist ii
  • The Bay Area Air Quality Management District
  • San Francisco, CA FULL_TIME
  • Description The Bay Area Air Quality Management District (Air District) is a regional government agency, committed to achieving clean air to protect the public's health and the environment. The Air Di...
  • 1 Month Ago

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Contract - Senior Quality Document Control Specialist
  • Cytokinetics
  • South San Francisco, CA FULL_TIME
  • Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatme...
  • 23 Days Ago

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0 Total Quality Senior Specialist jobs found in San Francisco, CA area

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Quality Specialist
  • Anatomage
  • Santa Clara, CA
  • Who is Anatomage? Founded in 2004, Anatomage is a world-leading health care technology company. Anatomage offers 3D medi...
  • 3/28/2024 12:00:00 AM

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Senior Manager, GMP Quality Assurance
  • Alumis Inc.
  • South San Francisco, CA
  • Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases...
  • 3/28/2024 12:00:00 AM

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Air Quality Specialist I/II
  • The Bay Area Air Quality Management District
  • San Francisco, CA
  • Description The Bay Area Air Quality Management District (Air District) is a regional government agency, committed to ac...
  • 3/27/2024 12:00:00 AM

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Surgical and Interventional Clinical Practice Quality Specialist (1.0 FTE, Days)
  • Lucile Packard Children's Hospital
  • Palo Alto, CA
  • Nursing Staff 1.0 FTE, 10 Hour Day Shift This position supports: OR, IR, PACU and Pre-Op At Stanford Children's Health, ...
  • 3/27/2024 12:00:00 AM

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Quality Inspector - Electronics Level 2
  • SQA Services
  • Sunnyvale, CA
  • Job Description Job Description Urgent need! Level 2 Electronics Inspector We are seeking a skilled and detail-oriented ...
  • 3/27/2024 12:00:00 AM

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Senior Air Quality Specialist/Engineer - Environmental Services (Multiple Locations)
  • Burns & McDonnell
  • Walnut Creek, CA
  • **Description** Burns & McDonnells regional operation in California (Los Angles office preferred) is looking for a Senio...
  • 3/26/2024 12:00:00 AM

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Teakwood by Burma Love: General Manager
  • Burma Inc
  • San Francisco, CA
  • Job Description Job Description Location: Hayes Valley, SF. Salary: $105,000-$120000 DOE. Calling the foodies, the passi...
  • 3/24/2024 12:00:00 AM

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Quality Specialist
  • CSL Plasma
  • Fairfield, CA
  • The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center...
  • 2/29/2024 12:00:00 AM

San Francisco is located on the West Coast of the United States at the north end of the San Francisco Peninsula and includes significant stretches of the Pacific Ocean and San Francisco Bay within its boundaries. Several picturesque islands—Alcatraz, Treasure Island and the adjacent Yerba Buena Island, and small portions of Alameda Island, Red Rock Island, and Angel Island—are part of the city. Also included are the uninhabited Farallon Islands, 27 miles (43 km) offshore in the Pacific Ocean. The mainland within the city limits roughly forms a "seven-by-seven-mile square", a common local collo...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Senior Specialist jobs
$140,339 to $166,984
San Francisco, California area prices
were up 4.5% from a year ago

Total Quality Senior Specialist in Columbia, SC
Likely to be either a specialist within a particular focus area for QHSE, e.g., environmental, transportation, training, etc., or is based at a specific location in a generalized role.
February 18, 2020