Quality Assurance

1 month ago

College Station, United States BioPharma Consulting JAD Group Full time
Job DescriptionJob Description

Summary: BioPharma Consulting JAD Group is seeking a highly skilled and experienced Quality Assurance - Compliance Specialist III to join our team. The Quality Assurance Compliance Specialist III - QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III – QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Functions:

  • Leadership o Provides QA support to the validation team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements, and partner commitments.
  • Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
  • Knowledge and understanding of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design fundamentals, SOPs, regulatory agency expectations and industry trends.
  • Reviews computer test automation scripts, creation, and deviation closure recommendations as required.
  • Set up and maintain QA Validation Monthly Tracker New Business Growth o Support client due diligence and Quality audits as well as regulatory inspections.
  • Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
  • Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions. Participate in design reviews and have experience in reading P&ID’s and various engineering drawings.
  • Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner.
  • Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as assigned.

Requirements

Qualifications:

  • Bachelor’s degree with three (3) years or more experience in Pharmaceutical or other regulated Industry OR
  • Associates Degree with five (5) years or more experience in Pharmaceutical or other regulated Industry OR
  • High school or equivalent with eight (8) years or more experience in Pharmaceutical or other regulated Industry
  • Preferred: Degree in Biology, Chemistry or Engineering

Required Skills & Abilities:

  • Experience with qualification/computer validation experience.
  • Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
  • Single Use and Process Validation a plus.
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills.
  • Proficient in Microsoft Excel, Word and PowerPoint.

  • Quality Assurance Specialist

    1 week ago

    College Station, Texas, United States Jobot Full time

    Quality Assurance Specialist needed for a leading manufacturer in the solar energy sector.This position is hosted by Jobot, a proud American company at the forefront of the solar energy industry.Our advanced manufacturing facility produces high-efficiency solar modules, recognized for their excellence, and provides comprehensive services to comply with...

  • Quality Assurance Specialist

    2 weeks ago

    College Station, Texas, United States Jobot Full time

    Quality Assurance Specialist needed for a leading company in the solar energy manufacturing sector.About Us:We are a proud American manufacturer, recognized as a leader in the solar energy field. Our cutting-edge production facility is dedicated to creating high-efficiency solar modules, ensuring compliance with the IRS' US-domestic production ITC adder...

  • Quality Assurance Engineer

    1 week ago

    College Station, Texas, United States Jobot Full time

    Quality Assurance Engineer sought for a leading manufacturer in the solar energy sector This opportunity is hosted by Jobot. A brief overview of our company: We take pride in being a leader in the solar energy market, producing high-efficiency solar modules and offering comprehensive services that align with industry standards. Our innovative manufacturing...

  • Quality Assurance Specialist

    2 days ago

    College Station, Texas, United States Jobot Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Jobot, a leading solar energy manufacturing industry leader. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesDevelop and Implement Quality Assurance ProtocolsDesign and...

  • Quality Assurance Manager

    2 days ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our products and processes.Key ResponsibilitiesDocument Review and Approval: Review and approve basic and...

  • Quality Assurance Specialist

    2 days ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesDocument Review and Approval: Review and approve basic and technical...

  • Quality Assurance Specialist

    5 days ago

    College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our suppliers and raw materials.Key ResponsibilitiesSupport the supplier quality program by ensuring all suppliers are qualified prior...

  • Quality Assurance Specialist in Biopharma

    5 days ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec, a leading global provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has been dedicated to delivering a comprehensive range of services that assist clients in achieving their...

  • Quality Assurance Specialist in Biopharma

    1 week ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec—a global leader in system validation and lifecycle services—focuses on the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in achieving their capital project...

  • Quality Assurance Specialist in Biopharma

    5 days ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec—a leading global provider of system validation and lifecycle services—specializes in the commissioning and qualification of computerized systems tailored for clients within the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in...

  • Quality Assurance Investigator

    7 days ago

    College Station, Texas, United States Medix™ Full time

    Position: Deviation InvestigatorKey Responsibilities:Conduct thorough investigations into process deviations, procedural anomalies, and nonconformance incidents.Ensure comprehensive analysis of root causes, corrective actions, and preventive measures (CAPA), along with assessment of product impact.Compile and document findings from investigations.Design,...

  • Quality Assurance Investigator

    1 week ago

    College Station, Texas, United States Medix™ Full time

    Position Title: Deviation InvestigatorKey Responsibilities:Conduct thorough investigations into process deviations, procedural anomalies, and nonconforming incidents.Ensure that root cause analysis, corrective actions, and preventative measures (CAPA) are comprehensively addressed in all investigations. Formulate actionable recommendations based on...

  • Automation Quality Assurance Specialist

    1 week ago

    College Station, Texas, United States BioPharma Consulting JAD Group Full time

    Automation Quality Assurance SpecialistAt BioPharma Consulting JAD Group, we are expanding our Automation division and are in search of talented Automation Quality Assurance Specialists. In this pivotal role, you will be responsible for delivering technical and operational assistance, executing essential projects, and overseeing automation systems to drive...

  • Quality Assurance Lead Auditor

    5 days ago

    College Station, Texas, United States FUJIFILM Diosynth Biotechnologies Full time

    About the RoleFUJIFILM Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Lead Auditor to join our Global Supplier Quality Management team. As a key member of our team, you will be responsible for leading and managing supplier audits, ensuring compliance with quality policies and site SOPs.Key ResponsibilitiesLeadership: Provide coaching...

  • Automation Quality Assurance Specialist

    1 week ago

    College Station, Texas, United States BioPharma Consulting JAD Group Full time

    Automation Quality Assurance Specialist - BioPharma Consulting JAD GroupAt BioPharma Consulting JAD Group, we are expanding our Automation division and are in search of proficient Automation Quality Assurance Specialists. In this pivotal role, you will be instrumental in delivering technical and operational assistance, executing essential projects, and...

  • Supplier Quality Assurance Lead Auditor

    2 weeks ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Position Overview At FUJIFILM Holdings America Corporation, we recognize the significance of our work and are eager to welcome skilled professionals to our team. As we expand our operations and enhance our capabilities, we seek dedicated individuals who are passionate about making a meaningful impact in the biopharmaceutical industry. Join us in our mission...

  • Senior Quality Assurance Specialist

    5 days ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at FUJIFILM Holdings America Corporation. As a key member of our quality assurance team, you will be responsible for implementing, upgrading, and maintaining comprehensive electronic cGMP systems that are compliant with regulated requirements.Key...

  • Compliance Investigator

    2 days ago

    College Station, Texas, United States Azzur Group Full time

    Job DescriptionAzzur Group is seeking a highly skilled Compliance Investigator to join our team. As a Compliance Investigator, you will play a critical role in ensuring the company's adherence to regulatory requirements and industry standards.Key Responsibilities:Investigations and Root Cause Analysis: Conduct thorough investigations into process excursions,...

  • Compliance and Quality Assurance Specialist I

    4 days ago

    College Station, Texas, United States Fujifilm Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist I - Audit and Compliance to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesSupport Audit Responsibilities: Collaborate with site...

  • Quality Assurance Specialist I

    5 days ago

    College Station, Texas, United States Fujifilm Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist I - Audit and Compliance to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesSupport Audit Responsibilities: Collaborate with site...