Quality Assurance Director jobs in Santa Ana, CA

Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Quality Specialist II, Quality Assurance
  • Dendreon Corporation
  • Seal Beach, CA OTHER
  • Overview

     Who we are.Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.

    If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.

    What we do.Vision – Pioneering the future of immunotherapy.Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

     

    How we do it.The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…

    • Put Patients First: Every day is a new opportunity to improve the lives of patients living with cancer.
    • Act with Integrity: Be honest, transparent, and committed to doing what’s right in every situation.
    • Build Trust: Building trust takes time. Engage teammates, be candid and transparent.
    • Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
    • Drive Results: Be accountable and execute – we win when everyone performs.

    Primed for Growth - Contract/Partner Manufacturing Business Unit.

    Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in

    cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.

     

    Are you ready?

    Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

     

    Summary

    The Quality Specialist II, Quality Assurance supports site Manufacturing Quality Assurance (MQA).  This role performs a wide variety of QA activities that align with policies, processes, procedures, and controls to ensure compliance with applicable regulatory requirements.  Primary responsibilities for this role are:

  • Perform activities related to batch record process flow (i.e. Issuance, Review, Closure)
  • Perform incoming receipt of patient material and packing of Final Product.
  • Perform Final Product disposition and release.
  • Perform Raw Material review and approval.
  • Review and approve GMP facility work orders.
  • Draft Biological Product Deviation Reports (BPDRs) for post distribution Nonconformances.
  • Author and review documents (i.e. Standard Operating Procedures; Reports).
  • Assist with the Training Program, as needed.
  • Initiates Nonconformances, as necessary.
  • Provide support for any other duties assigned
  • Responsibilities

    • Demonstrate interpersonal effectiveness skills.
    • Perform problem-solving skills effectively.
    • Demonstrate competent communication to effectively:
      • Provide knowledge/technology transfer for applicable quality systems
      • Communicate to management and the group with clarity, brevity, and accuracy
    • Ensure work is in compliance with required regulatory standards and conforms to company policies and Standard Operating Procedures (SOPs).
    • Recommend changes to policies and establishes procedures that affect immediate organization(s).
    • Provide timely quality support to stakeholders
    • Demonstrate skilled planning and organizing, and relationship building.
    • Collaborate with cross-functional teams and partners.
    • Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
    • Establish positive relationships and interfacing with internal, multi-functional departments.
    • Notify Senior Management regarding quality issues as required by site procedures for escalation and prepares reports as requested.

    Scope

    • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
    • Follows policies and procedures in selecting approaches and techniques to obtaining solutions.
    • Exercises judgment within defined procedures and practices to determine appropriate action.
    • Occasionally receives general instructions on routine work, detailed instructions on new assignments.

    Qualifications

    • BS in Life Sciences or other relevant scientific discipline
    • 5 years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred. 10 years of relevant work experience can be substituted for a 4-year course of study leading to a Bachelor’s degree.
    • Knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
    • Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.

    Skills

    • Strong attention to detail
    • Strong Interpersonal skills (i.e. communication) to interface effectively with all levels of colleagues in a team environment
    • Strong organizational skills related to priorities and workload
    • Ability to collaborate and foster internal teamwork with other cross-functional areas and sites
    • Ability to support or lead Quality Projects, as needed
    • Maintain the highest standards of ethical behavior
    • Ability to drive results through team assigned orientated tasks and responsibilities
    • Ability to manage multiple priorities and tasks in a fast pace, dynamic environment
    • Ability to exercise good judgment
    • Strong knowledge of cGMP
    • Ability to use computer programs

    Working Conditions and Physical Requirements

    • Ability to sit or stand for extended periods of time 
    • Intermittent walking to gain access to work areas
    • Finger dexterity sufficient to use a computer and to complete paperwork activities
    • Vision sufficient to use a computer, to read written materials and to complete paperwork activities
    • Hearing sufficient to communicate with individuals by telephone and in person
    • Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas
    • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 25 lbs. and occasionally up to 50 lbs
    • Ability to gown aseptically for work in Clean Room environments
    • Job performed in a lab, office, or utility (noisy) environment
    • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials
  • 21 Days Ago

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Quality Assurance Engineer II
  • Nihon Kohden Orange Med
  • Santa Ana, CA FULL_TIME
  • Job Purpose The Quality Assurance Engineer II works under the instruction of the Manager, Quality Engineering. This position helps to support the manufacturing of medical devices from a quality perspe...
  • 22 Days Ago

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Software Quality Assurance Tester
  • TAH Operations LLC (1LT)
  • Tustin, CA FULL_TIME
  • Tricon Residential Inc. (NYSE: TCN, TSX: TCN) is an owner and operator of a growing portfolio of more than 36,000 single-family rental homes in the U.S. Sun Belt and multi-family apartments in Canada....
  • 4 Days Ago

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Quality Assurance Technician
  • Actalent
  • Santa Ana, CA OTHER
  • Description: In need of quality assurance technicians that can come in and help with their QA functions. Will be held responsible for: Reviewing and editing batch records Assisting in Document Change ...
  • 5 Days Ago

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Software Quality Assurance Tester
  • Tricon Residential
  • Tustin, CA FULL_TIME
  • Tricon Residential Inc. (NYSE: TCN, TSX: TCN) is anownerand operatorofa growing portfolioof morethan 36,000 single-family rental homes in the U.S.Sun Beltand multi-familyapartmentsin Canada.Our commit...
  • 6 Days Ago

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Sr. Quality Assurance Engineer
  • Autonomous Medical Devices Inc.
  • Sunflower, CA FULL_TIME
  • Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Ea...
  • 10 Days Ago

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0 Quality Assurance Director jobs found in Santa Ana, CA area

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QA QC Director - Aseptic
  • Dechra Pharmaceuticals
  • Pomona, CA
  • Job Introduction Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in...
  • 3/29/2024 12:00:00 AM

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Director, Clinical QA (GCP) - Remote, US
  • Proclinical Staffing
  • Irvine, CA
  • Proclinical are recruiting for a Director, Clinical QA (GCP) to join a biotech organisation. This role is on a permanent...
  • 3/29/2024 12:00:00 AM

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Mental Health - Continuous Quality Improvement Analyst
  • SCHARP California
  • Los Angeles, CA
  • Job Description Job Description Under the direction of the Quality Assurance Director, the Continuous Quality Improvemen...
  • 3/28/2024 12:00:00 AM

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National Wastewater Practice Leader, Water
  • Gannett Fleming
  • Los Angeles, CA
  • Water is an essential part of life. We consider each water project an opportunity to innovate, evolve, and look at thing...
  • 3/28/2024 12:00:00 AM

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Mental Health - Continuous Quality Improvement Clinician
  • SCHARP California
  • Los Angeles, CA
  • Job Description Job Description Under the direction of the Quality Assurance Director, the Continuous Quality Improvemen...
  • 3/27/2024 12:00:00 AM

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Quality Supervisor
  • Bazz Houston International
  • Garden Grove, CA
  • Job Description Job Description COMPANY DESCRIPTION: Bazz Houston International is a custom metals manufacturer of Sprin...
  • 3/27/2024 12:00:00 AM

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Director Of Quality Assurance
  • Executive Alliance
  • Cypress, CA
  • Job Description Job Description Our client is seeking a talented and driven Director of Quality Assurance to join our te...
  • 3/26/2024 12:00:00 AM

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Director Quality Assurance
  • Direct Search Systems
  • Santa Ana, CA
  • Job Description Job Description Direct Search Systems is assisting our client in their search for a Director of Quality ...
  • 3/26/2024 12:00:00 AM

Santa Ana /ˌsæntə ˈænə/ (Spanish for "Saint Anne") is the county seat and second most populous city in Orange County, California in the Los Angeles metropolitan area. The United States Census Bureau estimated its 2011 population at 329,427, making Santa Ana the 57th most-populous city in the United States. Santa Ana is in Southern California, adjacent to the Santa Ana River, about 10 miles (16 km) from the coast. Founded in 1869, the city is part of the Greater Los Angeles Area, the second largest metropolitan area in the United States, with almost 18 million residents in 2010. Santa Ana is a ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Director jobs
$179,414 to $226,307
Santa Ana, California area prices
were up 2.5% from a year ago

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The Head of Quality Assurance plays a leadership position in the quality assurance department overseeing all the activities of the junior quality assurance teams.
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Quality Assurance is part of the manufacturing quality system.
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