Quality Assurance Coordinator

6 days ago

Emeryville, United States Teksky Inc Full time

**JOB: Quality Assurance Coordinator**

**Location: Emeryville, CA**

**Employment Type: On-site Full-time.**

**Position Summary**:
The Compliance Coordinator is responsible to ensure that all production paperwork is completed, collected, organized, reviewed, and filed to the satisfaction of all pertinent regulatory agencies and customers. Ensuring the site is always audit-ready by maintaining GMP, Organic, SQF, and any other certifications. Ensuring the quality of all incoming ingredients, batches, and finished products. Performs required quality testing of products and records accurate product specifications in a timely manner.
- Maintain a solid and up-to-date understanding of all regulatory issues pertaining to the completion, review, and filing of production paperwork.
- Maintain a solid and up-to-date understanding of all customer requirements and preferences pertaining to the completion, review, and filing of production paperwork.
- Collect all production paperwork, ensuring that any missing paperwork is located.
- Provide aggressive reporting and retraining for all incomplete, incorrect, or non-compliant paperwork.
- Organize paperwork per established filing system.
- Review paperwork, ensuring that all process CCP’s, quality specifications, and customer requirements have been met. Any product affected by deviations or missing records must be reported to QA and placed on QA hold.
- Manage filing system such that all completed and reviewed records are maintained and accessible for the time required by customers and regulatory agencies.
- Release product.
- Provide assistance/support as needed with the customer, government, and third-party audits.
- Ensure all products meet the customer and product requirements.
- Always keep all work areas and equipment within SQF standards and clean.
- Ensure all personal protective equipment is always properly worn.
- Ensure all equipment is set up, calibrated, and functioning properly throughout your shift.
- Keep all equipment that is used clean, in your area always, and prepared for the next run.
- Perform several checks to the batches such as Colour, pH & sensory.
- Use the following equipment, Refractometer, pH Meter, Colour Meter, Moisture Meter, Viscometer, and Consistometer, various gages, and torque meters.
- Obtain batch samples by opening kettles, turning off agitators, ladle the samples, place samples in beakers, and take to QC Bench for testing.
- Obtain liquid ingredient samples from bulk containers and perform testing on them.
- Recommend adjustments be made to batches by adding or subtracting ingredients.
- Monitor the Filler Machine and lines by checking the weights, charts, codes, labelling, pasteurizer temperatures and perform hourly finished product analysis.
- Verify codes and charts very closely
- the ink can run dry, and codes can be set wrong.
- Perform visual checks and record results, weigh product on calibrated scales, obtain and bring the samples to the QC bench for testing, perform tests, and record results.
- Place batches of finished products on hold as required.
- Copy batch cards as required for kitchen operators.
- All other assigned duties required during your work period.

**Required Skills and Experience**:

- GED or High School Diploma
- Ability to work with numbers, perform calculations, and possess mechanical abilities.
- Demonstrated ability to work independently, with limited supervision.
- Communication Skills
- must work closely with all departments and management levels.
- Keep up with a fast-paced work environment and record data as required in a timely manner.
- Extreme attention to detail.
- Strong organizational ability.
- Ability to work independently.
- Ability to work with multiple departments.
- Good communication skills (both written and verbal).
- General computer proficiency (Word, Excel, etc).
- Ability to attend and successfully complete related training programs.

**Equipment and Tools Used**:

- Use the following equipment: Refractometer, Salt Titrator, Acid Titrator, PH Meter, Colour Meter, Moisture Meter, Viscometer, and Consistometer, various gages, torque meters and other odd equipment as required.
- Handcarts and pallet jacks
- Forklift (not all QC Techs.)

**Working Conditions, Environment, Mobility, and Physical Effort**:

- The temperature in the work area varies.
- The environment is very wet, slippery, and has continuous forklift traffic.
- Handle and work around various moving equipment and chemicals.
- Frequent use of hot/cold water to perform checks and clean equipment and area.
- Frequent lifting objects < 30 lbs and pushing/pulling of objects less than

  • Director, Clinical Quality Assurance

    4 weeks ago

    Emeryville, California, United States 4D Molecular Therapeutics Full time

    Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...

  • Director, Clinical Quality Assurance

    1 month ago

    Emeryville, California, United States 4D Molecular Therapeutics Full time

    Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...

  • Director, Clinical Quality Assurance

    2 months ago

    Emeryville, United States 4D Molecular Therapeutics Inc. Full time

    Position Summary: The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP).  This position reports to the Senior Director, GCP...

  • Director, Clinical Quality Assurance

    4 weeks ago

    Emeryville, United States 4D Molecular Therapeutics Inc. Full time

    Position Summary: The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP).  This position reports to the Senior Director, GCP...

  • Quality Assurance Technician

    2 weeks ago

    Emeryville, United States Petit Pot Full time

    About Petit Pot In 2014, while trying to find the perfect dessert to go with dinner, French pastry chef Maxime realized something was missing in his local grocery store: Pot de crème! As a fan of all things sweet, Maxime decided to address this craving by founding Petit Pot in San Francisco to bring not only pot de crème but a portfolio of delicious...

  • Director, Clinical Quality Assurance

    1 month ago

    Emeryville, United States 4D Molecular Therapeutics Full time

    Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...

  • Director, Clinical Quality Assurance

    1 month ago

    Emeryville, United States BioSpace Full time

    Job Details Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your...

  • Director, Clinical Quality Assurance

    4 weeks ago

    Emeryville, United States BioSpace Full time

    Job Details Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your...

  • Director, Clinical Quality

    1 month ago

    Emeryville, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...

  • Director, Clinical Quality

    4 weeks ago

    Emeryville, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...

  • Director, Clinical Quality

    1 month ago

    Emeryville, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...

  • Director, Clinical Quality

    4 weeks ago

    Emeryville, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...

  • Director of Clinical Quality Compliance

    5 days ago

    Emeryville, United States Kyverna Therapeutics, Inc. Full time

    Kyverna Therapeutics is a patient–centered, clinical–stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at...

  • Administrative Coordinator, Auditor Hub

    3 weeks ago

    Emeryville, United States SCS Global Services Full time

    **Company Overview** **Job Overview** The Administrative Coordinator role will support the Auditor Hub team at SCS Global Services. This position is responsible for providing support for auditor onboarding, performance tracking, qualifications, communications, and training at the corporate level. This position requires the Administrative Coordinator to...

  • Patient Care Coordinator

    3 weeks ago

    Emeryville, United States Stanford Health Care Full time

    1.0 FTE Full time Day - 08 Hour R2439745 Onsite 78801 ITA EMERYVILLE TECH Allied Health 5800 Hollis St,EMERYVILLE,California If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of America) Stanford...

  • Document Control Assistant, Quality Assurance

    2 weeks ago

    Emeryville, United States SCS Global Services Full time

    **Company Overview** **Job Overview** **Essential Duties and Responsibilities** - Assist in maintaining the integrity of working documents and updating documentation when revised - Assist in maintaining the document control system - Ensure all documentation assigned for review meets formal corporate requirements **Minimum Qualifications** - High School...

  • Patient Care Coordinator Ii

    5 days ago

    Emeryville, United States Stanford Health Care Full time

    1.0 FTE Full time Day - 08 Hour R2439007 Onsite 71844 EHC - MULTISPECIALTY CLINIC I Allied Health 5800 Hollis St,EMERYVILLE,California If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of...

  • Project Coordinator

    1 week ago

    Emeryville, United States MB Jessee Painting Inc Full time

    Project Coordinator **(Bilingual in Spanish is a plus!)** **MB Jessee Painting **of **Oakland, CA** is looking to hire a **Project Coordinator**. The Project Coordinator is overall responsible for ensuring that the customer is cared for from the point of sale through the end of production. This position coordinates the details necessary to make the...

  • Quality Lab Technician

    1 month ago

    Emeryville, United States Premier Nutrition Full time

    Business Unit Overview Here's what all the hype is about: Premier Nutrition Company (PNC) is one of the fastest-growing companies in the convenient nutrition space showing clear leadership in the category of protein shakes and protein powders. We make the brands Premier Protein, Dymatize, and PowerBar, which is sold internationally, and we are part of our...

  • Quality Lab Technician

    4 weeks ago

    Emeryville, United States Michael Foods Full time

    Business Unit Overview Here's what all the hype is about: Premier Nutrition Company (PNC) is one of the fastest-growing companies in the convenient nutrition space showing clear leadership in the category of protein shakes and protein powders. We make the brands Premier Protein, Dymatize, and PowerBar, which is sold internationally, and we are part of our...