Senior Specialist, Quality Assurance Expert

1 week ago

Roseville, United States Hispanic Technology Executive Council Full time

Quality Assurance Role at Hispanic Technology Executive Council

At Hispanic Technology Executive Council, we are seeking a highly skilled Senior Specialist, Quality Assurance to join our team. This role will be responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Key Responsibilities:

  • Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
  • Conduct quality reviews and approval/release decisions at a regulated manufacturing facility.
  • Handle CGMP documentation review related to product release, facilities, and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
  • Establish and report metrics related to products and processes as deemed necessary by the Regional Quality Manager.
  • Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
  • Handle and ensure quality of documentation (control, retention, and archival) to support CGMP activities.
  • Engage and collaborate with operations department to drive quality system and CGMP requirements.
  • Perform product release activities per CGMP requirements.
  • Monitor CAPA in investigations and close when completed or escalate (if necessary).
  • Perform aseptic review of the site with operations and document results.
  • Report quality system issues to the RQM and others as necessary.

Requirements:

  • Bachelor's degree in a related field or equivalent work experience.
  • 2-4 years of experience in quality assurance or a related field.
  • Proficiency with MS Excel and MS Word.
  • Effective written and verbal English communication skills.
  • Strong attention to detail.
  • Ability to lift between 30-45 lbs.
  • Pharmaceutical or medical device experience a plus.
  • ISO experience a plus.

Work Environment:

  • The primary work environment consists of a manufacturing pharmacy that must be kept clean, orderly, properly lighted, and maintained in optimum operating condition.
  • Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.
  • The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group.

What We Offer:

  • A competitive salary range of $74,500-$106,400.
  • A comprehensive benefits package, including medical, dental, and vision coverage, paid time off, health savings account, 401k savings plan, and more.

  • Senior Specialist, Quality Assurance

    7 days ago

    Roseville, United States Hispanic Technology Executive Council Full time

    Quality Assurance Specialist, SeniorAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist, Senior to join our team at Hispanic Technology Executive Council. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, and contributing to the development and implementation...

  • **Senior Quality Assurance Engineer**

    2 weeks ago

    Roseville, United States BCForward Full time

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at BCForward. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our products and services.Key ResponsibilitiesDevelop and execute comprehensive testing strategies to identify and resolve defectsCollaborate...

  • Quality Assurance Specialist

    1 day ago

    Roseville, Michigan, United States Chili's Grill & Bar Full time

    Job SummaryWe are seeking a Quality Assurance Specialist to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist, you will be responsible for ensuring that every Guest receives perfectly prepared, high-quality food. You will provide dependable, fast service that is absolutely Chili's.About the RoleThis is a fast-paced environment where you...

  • Quality Assurance Specialist

    2 weeks ago

    Roseville, Michigan, United States Chili's Grill & Bar Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist - Expeditor to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist - Expeditor, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food in a timely manner.Key ResponsibilitiesFood Preparation and Quality Control:...

  • Quality Assurance and Compliance Specialist

    2 weeks ago

    Roseville, California, United States Bosch USA Full time

    About the Role:Bosch USA is seeking a highly skilled Quality Assurance and Compliance Specialist to join our team. As a Quality Management and Methods Auditor, you will be responsible for ensuring the highest standards of quality and compliance across our operations.Key Responsibilities:Conduct process, product, and system audits to ensure compliance with...

  • Quality Assurance Specialist

    3 weeks ago

    Roseville, United States Amano McGann, Inc. Full time

    Position Title: Quality Assurance Engineer Location: Roseville, MN Department: Quality Assurance Employment Type: Full Time Minimum Experience: 5 years Overview Amano McGann, Inc. (AMI) is seeking a dedicated Quality Assurance Engineer to join our team in Roseville, Minnesota. This pivotal role is essential for ensuring the excellence of software and...

  • Quality Assurance and Audit Specialist

    3 weeks ago

    Roseville, California, United States Bosch USA Full time

    Company OverviewThe Bosch Group is a global leader, operating in numerous countries worldwide. With a workforce exceeding 400,000 associates, a career at Bosch provides an opportunity to develop a remarkable career in an environment that values diversity, initiative, and a commitment to achieving results.If you are passionate about advancing technology,...

  • Automotive Quality Assurance Specialist

    3 weeks ago

    Roseville, California, United States EchoPark Automotive Full time

    Job Overview:EchoPark Automotive is seeking an Automotive Quality Assurance Specialist to join our dynamic team. As a vital member of our reconditioning unit, you will play a key role in the inspection and quality assessment of our nearly-new, low-mileage vehicles that are being prepared for the market. Our comprehensive 190-point mechanical and safety...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Roseville, California, United States Penumbra Full time

    Overview As a Senior Quality Assurance Engineer, you will independently design and execute essential quality system components to guarantee the superior quality of both new and existing products, ensuring adherence to relevant regulations and standards. You will tackle complex issues where the evaluation of situations or data necessitates a thorough analysis...

  • Quality Assurance Specialist

    17 hours ago

    Roseville, California, United States Mechanics Bank Full time

    Quality Assurance Associate - Commercial LendingMechanics Bank is seeking a Quality Assurance Associate - Commercial Lending to ensure the quality and accuracy of lending processes. This role will be responsible for conducting audits and reviews to identify errors or discrepancies and working closely with the lending team to address and resolve issues.Key...

  • Quality Assurance Supervisor

    2 weeks ago

    Roseville, United States Bimbo Bakeries USA Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Supervisor to join our team at Bimbo Bakeries USA. As a Quality Assurance Supervisor, you will be responsible for ensuring superior quality and promoting a culture of food safety among all bakery associates.Key Responsibilities:Assist in maintaining audit-ready compliance to all internal and...

  • Quality Assurance Engineer Associate

    3 weeks ago

    Roseville, United States Amano McGann, Inc. Full time

    Position Title: Quality Assurance Engineer Location: Roseville, MN Department: Quality Assurance Employment Type: Full Time Minimum Experience: 5 years Overview Amano McGann, Inc. (AMI) is seeking a dedicated Quality Assurance Engineer in Roseville, Minnesota. This pivotal role is essential to the engineering team, focusing on the quality assurance of...

  • Junior Quality Assurance Engineer

    3 weeks ago

    Roseville, United States Amano McGann, Inc. Full time

    Position Title: Quality Assurance Engineer Location: Roseville, MN Department: Quality Assurance Employment Type: Full Time Minimum Experience: 5 years Overview Amano McGann, Inc. (AMI) is seeking a dedicated Quality Assurance Engineer to join our team in Roseville, Minnesota. This pivotal role is essential to our engineering team, focusing on the quality...

  • Technologist: Laboratory

    2 weeks ago

    Roseville, United States Crimson Ventures Full time

    We are a leading manufacturer of high-quality wood-based materials worldwide. Since our business began in 1897 with a single sawmill, Crimson Ventures has developed a unique supply chain with over 35 production sites and 21 distribution centers in 28 countries and more than employees around the world. This includes around 600 employees at our location, one...

  • Quality Assurance and Quality Control Food

    4 weeks ago

    Roseville, United States PrideStaff Full time

    PrideStaff is working with a key client in the Roseville area to identify the right individual with Quality Control experience specific to food processing. This position is full time with the potential to be temp to hire. :This associate would consistently complete quality assurance activities to support the production of first quality finished product....

  • Associate Quality Assurance Engineer

    4 months ago

    Roseville, United States Amano McGann, Inc. Full time

    Title/Position: Quality Assurance Engineer Location: Roseville, MN Department: Quality Assurance Employment Type: Full Time Min. Experience: 5 years Description Amano McGann, Inc. (AMI) has an opening for a Quality Assurance Engineer in Roseville, Minnesota. This important position involves being a key member of the engineering team, ensuring quality of...

  • Quality Assurance Specialist Food Production

    6 days ago

    Roseville, United States PrideStaff Full time

    Quality Assurance and Quality Control Food Job DescriptionPrideStaff is working with a key client in the Roseville area to identify the right individual with Quality Control experience specific to food processing. This position is full time with the potential to be temp to hire.Key Responsibilities:Ensure plant cleanliness by communicating issues and...

  • Quality Assurance and Methods Evaluator

    3 weeks ago

    Roseville, California, United States Bosch Group Full time

    Career Opportunity at Bosch GroupBecome a vital part of Bosch Group, a renowned leader in technology and innovation. Our dedication to quality and inclusivity fosters a stimulating environment for professional advancement.We are on the lookout for a Quality Assurance and Methods Evaluator to enhance our team. In this position, you will be tasked with...

  • Automotive Quality Assurance Inspector

    3 weeks ago

    Roseville, United States EchoPark Automotive Full time

    Join EchoPark Automotive as an Automotive Quality Assurance Inspector!As a vital member of our reconditioning team, you will play a key role in the inspection and quality assurance of our nearly-new, low-mileage vehicles that are being prepared for sale. Our comprehensive 190-point mechanical and safety evaluation, combined with our meticulous cosmetic...

  • Automotive Quality Assurance Technician

    3 weeks ago

    Roseville, United States EchoPark Automotive Full time

    Join EchoPark Automotive as an Automotive Quality Assurance Technician!As a vital member of our reconditioning team, you will play a key role in the movement and quality assessment of our nearly-new, low-mileage vehicles that are being prepared for sale. Our comprehensive 190-point mechanical and safety inspection, combined with our meticulous cosmetic...