Quality Assurance Document Control Specialist

2 weeks ago

San Pablo, United States 153136 JOINN Biologics Full time
Job DescriptionJob DescriptionDescription:

JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process development, downstream process development, analytical services. The company also provide therapeutic protein drug cGMP manufacturing, from GLP IND to clinical phase manufacturing. There is a collaboration opportunity for clinical phase III and commercial stage cGMP manufacturing.

Requirements:

Duties and Responsibilities:

• Manage document management in the EDMS System.

• Enter and assign training in the LMS System.

• Manage document product lot numbering system and labeling.

• Organize files and cabinets and label them appropriately.

• Provide QA evaluation of discrepancies, offering suggestions for improvement.

• Collaborate with external groups.

• Support internal and external inspections and audits.

• Create and revise SOPs or other QA & Compliance documents.

• Manage the Quality System records storage and archival processes.

• Manage vendor qualifications.

• Manage the document control function, ensuring documents are initiated, reviewed, revised, filed, and archived in a timely and compliant manner.

• Perform other Quality System duties in support of the Quality Assurance function as needed.

• Assist with and may be assigned a lead role on special projects with considerable complexity.

• Serve as the company Training Coordinator to initiate, monitor, and record training assignments and completions for all personnel. Maintain metrics and routinely report training status to executive management.

• Monitor risk management activities.


Qualifications/Experience:

• Bachelor’s degree in a scientific/technical discipline related to biology, biotechnology,

chemistry, or pharmaceutics.

• 2+ years of related experience in the biopharmaceutical industry with an emphasis on

Document Control, Quality Control, Engineering, or Manufacturing in a GMP regulated

industry, or an equivalent combination of education and experience.

• Previous work experience in a GMP environment and exposure to manufacturing records,

testing reports, and SOPs.

• Knowledge of GMP regulations and an understanding of FDA and other regulatory

guidelines.

• Proficiency in IT systems and software.

• Proven ability as a team player.

• Strong analytical and problem-solving skills.

• Ability to professionally express views and opinions.

• Good listening skills and the ability to accept conflicting points of view.

• Strong verbal and written communication skills.

• Strong organizational skills with attention to detail.

• Ability to navigate different personality styles in a large, complex organization in a

professional manner.

• Ability to juggle multiple priorities.

• Strong leadership principles, focusing on developing the best team and delivering results

in line with expectations."

  • Senior Quality Assurance Specialist

    2 weeks ago

    San Antonio, United States Extremity Care Full time

    Job DescriptionJob DescriptionSalary: $60,000.00Purpose:The Senior Quality Assurance Specialist is responsible for verifying operational compliance with the quality system and ensuring that all products and quality control processes meet established quality requirements.Duties & Responsibilities: Review HCT/P donor records in accordance with standard...

  • Quality Assurance Specialist

    3 weeks ago

    San Antonio, United States Extremity Care Full time

    Job DescriptionJob DescriptionSalary: $24.04 an hourPurpose:The Quality Control Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.Duties & Responsibilities: Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements. Sort and segregate...

  • Quality Assurance Specialist

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    San Francisco, United States GForce Life Sciences Full time

    ResponsibilitiesFamiliarity and proficiency in performing all responsibilities of the Quality Associate.Subject Matter Expertise in one or more specific Quality processes such as incoming inspection, change management, or records management. Also supports record administration and batch record review, including Certificate of Analysis/Conformance creation...

  • Quality Control Specialist

    16 hours ago

    San Antonio, United States Extremity Care Full time

    Job DescriptionJob DescriptionSalary: Purpose:The Quality Control Specialist is responsible for supporting production by ensuring that all products, donor records and quality control processes meet established quality requirements.This support is achieved through batch record review, verification of adherence to equipment maintenance/calibration schedules,...

  • Senior Quality Assurance Specialist

    2 weeks ago

    San Jose, United States CareerBuilder Full time

    Senior Quality Assurance Specialist (Contract) You want to make a difference and have an impact You enjoy having an influence in your day to day work You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow You wake up every day and do what you do If this sounds like you, youve come to the right...

  • Supplier Quality Assurance Specialist

    2 weeks ago

    San Leandro, United States RadNet Full time

    Recommend approval or rejection of potential new suppliers, ingredients, or packaging based on thorough assessments of quality and food safety systems against Ghirardelli policies. Effectively communicate decisions to internal and external parties Manage corrective and preventative actions for Ghirardelli supplier quality-related issues and non-conformances,...

  • Quality Assurance Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    San Jose, United States Medix™ Full time

    Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year! Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and...

  • Quality Assurance Specialist

    Found in: Appcast US C2 - 2 weeks ago

    San Jose, United States Medix™ Full time

    Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year! Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and...

  • Quality Control Administrator

    21 hours ago

    San Antonio, United States Total Aerospace Services Full time

    Quality Control Position: Quality Control Administrator (NOT REMOTE)Location: San Antonio, TXPay: $22/hrDuration: 3 months with a high probability of extension (contract; full time)Job Summary:Our client in San Antonio, TX is seeking a detail-oriented Quality Control Administrator to ensure the efficient maintenance and management of all quality control...

  • Quality Assurance Manager

    23 hours ago

    San Francisco, United States Kimmel & Associates Full time

    About the Company: A prominent construction firm known for their integrity, innovation, and commitment to quality, whose team-oriented environment fosters continuous learning and a strong work-life balance is currently seeking a Quality Assurance Manager. Our client specializes in various construction projects, with a focus on safety and excellence.About the...

  • Quality Assurance Associate

    22 hours ago

    San Diego, United States Pharmaron Full time

    Position: Quality Assurance AssociateDepartment: Quality AssuranceFLSA Status: Non-ExemptLocation: Carlsbad, CA (On-site)Position Description: The Quality Assurance Associate will play a vital part in maintaining and enhancing our Quality Systems. Reporting directly to the Senior Manager QA, you'll actively participate in various Quality Systems, lead...

  • quality assurance specialist

    Found in: beBee jobs US - 2 weeks ago

    Naval Station Complex, San Diego, United States Department Of The Navy Full time

    Summary This is a public notice flyer to notify interested applicants of anticipated vacancies. Applications will not be accepted through this flyer. Interested applicants must follow the directions in the "How to Apply" section of this flyer to be considered. There may or may not be actual vacancies filled from this flyer. Notice of Result letters will not...

  • Quality Assurance Manager

    1 week ago

    San Francisco, United States Kimmel Associates Full time

    About the Company: A prominent construction firm known for their integrity, innovation, and commitment to quality, whose team-oriented environment fosters continuous learning and a strong work-life balance is currently seeking a Quality Assurance Manager. Our client specializes in various construction projects, with a focus on safety and excellence. About...

  • Senior Quality Assurance Specialist

    2 weeks ago

    San Jose, United States Kymanox Full time

    Description Position at Kymanox Is Kymanox the right fit for you? You want to make a difference and have an impact... You enjoy having an influence in your day to day work... You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow... You wake up every day and do what you do because patients deserve...

  • Document Controls Specialist III

    47 minutes ago

    San Antonio, United States HNTB Full time

    Position or Keyword (Leave blank to see all)What We're Looking ForAt HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country. With our historic growth, it is an...

  • Quality Assurance Associate

    2 weeks ago

    San Diego, United States Proven Recruiting Full time

    Quality Assurance Associate If culture and mentorship are your priorities - you've found your match. This pioneer company in immune-oncology is looking to support and promote a talented QA Associate who will assist in the analytical methods of cancer cells. The ideal professional will have a strong background in aseptic technique and adherent mammalian cell...

  • Senior Quality Assurance Specialist

    1 day ago

    San Jose, United States Kymanox Full time

    Description Position at Kymanox Is Kymanox the right fit for you? You want to make a difference and have an impact... You enjoy having an influence in your day to day work... You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow... You wake up every day and do what you do because patients...

  • Quality Assurance Manager

    2 weeks ago

    San Francisco, United States NCW Full time

    Job DescriptionJob DescriptionPOSITION SUMMARY The Quality Assurance Manager’s primary responsibility is to perform peer reviews of design documents for constructability issues specific to accessibility regulations, waterproofing, roofing assemblies, windows and storefronts, and other areas of high risk. Occasional travel is required. This position reports...

  • QUALITY ASSURANCE SPECIALIST

    Found in: Dice One Red US C2 - 2 weeks ago

    San Diego, United States Department of the Navy Full time

    Summary You will serve as a Quality Assurance Specialist (QAS) in the San Diego Detachment, Quality Assurance (QA) Division of SUPERVISOR OF SHIPBUILDING BATH. Duties * You will provide primary contractual and quality oversight of the Government contracted Ship building and repair efforts conducted by the National Steel and Shipbuilding Company, and other...

  • Quality Assurance Specialist

    Found in: Appcast US C2 - 7 days ago

    San Jose, United States Medix™ Full time

    Primary Responsibilities:- Perform investigations per established procedures- Support problem solving and troubleshooting as part of investigations- Generate quality records as needed (CAPAs, CCs) to support process improvements- Review laboratory records (test packets, logbooks, etc.) and ensure they haveacceptable Good Documentation Practices and are...