Quality Assurance Manager - Healthcare jobs in San Jose, CA

Quality Assurance Manager - Healthcare manages and implements the quality management and quality improvement programs for a healthcare facility. Oversees quality assurance and compliance functions. Being a Quality Assurance Manager - Healthcare ensures programs and services are implemented at the highest standards and patients receive the highest level of care. Responsible for monitoring and updating policies and procedures to include regulatory changes. Additionally, Quality Assurance Manager - Healthcare requires a bachelor's degree. Requires a certification of registered nurse. Typically reports to a head of a unit/department. The Quality Assurance Manager - Healthcare 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 Manager - Healthcare 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 Assurance Manager
  • Zevacor Pharma, Inc
  • Gilroy, CA FULL_TIME
  • Overview

    SOFIE is committed to all aspects of Quality and Compliance in the manufacture of Radiopharmaceutical products. This role provides Quality leadership to defined SOFIE facilities (and the network). SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will play an active and integral part of the Quality team supporting compliance and improvement for an assigned SOFIE facility (or facilities). The applicant will be responsible for the Quality Management System (QMS) at the given SOFIE facility (or facilities) and manage the site Quality Assurance Specialist(s). The candidate must be strong at technical and quality writing, root cause analysis, identifying trends, and establishing and implementing robust corrective and preventive actions. The candidate must also be able to learn technical, scientific, and quality processes to aid in the oversight of SOFIE and Partner drug products.

     

    Essential Duties and Responsibilities

    ▪     Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, by implementing an effective and efficient quality management system and maintaining a state of cGMP control for sites within a given region.

    ▪     Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).

    ▪     Oversee all quality-related activities of routine radiopharmaceutical manufacture and directly supervise site-level Quality Assurance Specialists within a given facility or facilities.

    ▪     Release clinical and commercial finished product batches, final drug product labels, reagents, manufacturing batch records, associated EM data, QC analytical testing results, and Certification of Analysis for conformance to SOPs, specifications, regulations, and other applicable acceptance criteria to ensure compliance and product quality as required.

    ▪     Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites. Closely track and follow up on these activities for timely closure. Ensure that scientifically sound investigations are conducted and root causes are identified. Initiate and implement CAPA plans. Evaluate the effectiveness of the CAPA plans through reporting and trending.

    ▪     Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.

    ▪     Monitor and oversee the ongoing training program to qualify the site QASs to follow SOPs to perform their job functions at all times. Ensure the training covers any newly released procedures, revised procedures, and cGMP updates. Track individuals’ training requirements and ensure all trainings are on time and documented.

    ▪     Ensure aseptic operations are in compliance with internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations for sites within a given site. Assure completeness, accuracy, traceability, and compliance of the site’s utility and facility monitoring methods and records.

    ▪     Monitor the metrology program for given site(s). Ensure that all equipment is appropriately maintained, calibrated/recalibrated, or validated/revalidated in a timely manner. Ensure a comprehensive tracking system is implemented and followed.

    ▪     Ensure that raw materials, components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria before use for sites within a given region. Ensure all materials are properly organized, controlled, and secured.

    ▪     Provide QA oversight of manufacturing, QC, and other cGMP activities for sites within a given region. Identify non- compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site-level and resolve quality related issues.

    ▪     Regularly conduct internal self-audit for quality management system effectiveness for sites within a given region. Document the findings in a self-audit report. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.

    ▪     Liaise with corporate QA audits, customer audits, and regulatory agency audits. Perform readiness assessment

    ▪     Other responsibilities as required.

    ▪     The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements.  Duties, responsibilities, and requirements may change over time and according to business need.

     

    Qualifications

    ▪     Bachelor’s Degree required (science, technical, or quality degree preferred)

    ▪     4 years of work experience in Quality Assurance in a cGMP pharmaceutical and/or biological manufacturing regulated environment.

    ▪     2 years’ supervisory experience within a Quality Assurance or Quality Control function.

    ▪     Experience leading internal audits preferred.

    ▪     Knowledge of USP, FDA, and cGMP regulations preferred.

    ▪     Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required.

    ▪     Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required.

    ▪     Ability to prepare and present written and verbal reports to upper management required.

    ▪     Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

    ▪     Knowledge of how and ability to write, review, and revise exception reports and SOPs required.

    ▪     Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

    ▪     Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

    ▪     Ability to write reports, business correspondences, and procedure manuals required.

    ▪     Ability to effectively present information, deliver training, and respond to questions from groups of colleagues, managers, partners, and customers required.

    ▪     Ability to define problems, collect data, establish facts and draw valid conclusions required.

    ▪     Ability to solve problems and handle issues required.

    ▪     Proficient in MS Office applications required.

    ▪     Travel: up to 40% domestically.

     


    About the Company:
    Zevacor Pharma, Inc



    Industry:
    Biotechnology/Pharmaceuticals


  • 20 Days Ago

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Software Quality Assurance Manager
  • Diagnose Early Holdings, Inc.
  • Menlo, CA FULL_TIME
  • About Diagnose Early - Diagnose Early is bringing non-invasive biometric and medical testing to the world. We improve and lengthen life through the development and deployment of unique measurement and...
  • 22 Days Ago

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Manager, Clinical Quality Assurance
  • Corcept Therapeutics
  • Menlo, CA FULL_TIME
  • The Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical...
  • 9 Days Ago

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Manager of Quality Assurance
  • DeepSight Technology
  • Santa Clara, CA FULL_TIME
  • DeepSight Technology Inc. is a stealth-mode startup company that has developed breakthrough technology in ultrasound imaging. This new technology will both extend the range and clarity over current sy...
  • 12 Days Ago

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Quality Assurance Manager
  • Actalent
  • Mountain View, CA FULL_TIME
  • Description:The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician andhospital/clinic expectations. The department plays a vital r...
  • 12 Days Ago

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Quality Assurance Manager
  • Precision Measurements Inc.
  • San Jose, CA FULL_TIME
  • Quality Assurance Manager: Precision Measurements, Inc. is an ISO 9001:2015 Quality certified and ISO/IEC 17025:2017 ANSI/NCSL Z540-1-1994 (R2002) Accredited Metrology Laboratory located in San Jose, ...
  • 14 Days Ago

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0 Quality Assurance Manager - Healthcare jobs found in San Jose, CA area

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Director of Quality Management / Registered Nurse
  • Healthcare Support
  • San Leandro, CA
  • Director of Quality Management HealthCare Support is actively seeking a Director of Quality Management to fill an openin...
  • 3/28/2024 12:00:00 AM

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Therapy Development Specialist - San Francisco Bay Area
  • BAXTER
  • San Jose, CA
  • Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standa...
  • 3/28/2024 12:00:00 AM

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Medical Assistant Lead- Pediatric Specialties (Travel required)
  • Sutter Health
  • San Jose, CA
  • We are so glad you are interested in joining Sutter Health! Organization: PAMF-Palo Alto Medical Foundation ALD Position...
  • 3/28/2024 12:00:00 AM

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UX Product Design Intern, Sports
  • Roku
  • San Jose, CA
  • Teamwork makes the stream work. Roku is changing how the world watches TV Roku is the #1 TV streaming platform in the US...
  • 3/28/2024 12:00:00 AM

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Primary Care Physician - Sign-On Bonus Available
  • One Medical
  • San Jose, CA
  • About Us One Medical is a primary care solution challenging the industry status quo by making quality care more affordab...
  • 3/27/2024 12:00:00 AM

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Office Medical Director - Sign-On Bonus Available
  • One Medical
  • San Jose, CA
  • About Us One Medical is a primary care solution challenging the industry status quo by making quality care more affordab...
  • 3/27/2024 12:00:00 AM

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Radiologic Technologist II - Part Time
  • Sutter Health
  • San Jose, CA
  • We are so glad you are interested in joining Sutter Health! Organization: PAMF-Palo Alto Medical Foundation CAD Position...
  • 3/26/2024 12:00:00 AM

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Environmental Health and Safety Compliance Specialist - SCVHHS
  • County of Santa Clara, CA
  • San Jose, CA
  • Salary : $138,161.92 - $167,970.40 Annually Location : San Jose Metropolitan Area, CA Job Type: Full-Time Job Number: 24...
  • 3/26/2024 12:00:00 AM

San Jose is located at 37°20′07″N 121°53′31″W / 37.335278°N 121.891944°W / 37.335278; -121.891944. According to the United States Census Bureau, the city has a total area of 180.0 sq mi (466 km2), of which 3.4 sq mi (8.8 km2) (1.91%) is water, making it the fourth-largest California city by land area (after Los Angeles, San Diego and California City). San Jose lies between the San Andreas Fault, the source of the 1989 Loma Prieta earthquake, and the Calaveras Fault. San Jose is shaken by moderate earthquakes on average one or two times a year. These quakes originate just east of the city on...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Manager - Healthcare jobs
$127,348 to $161,892
San Jose, California area prices
were up 2.9% from a year ago

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