GLP Study Director

1 week ago

Culver City, United States BayOne Solutions Full time

GLP Study Director

Duration: 03 Months Contract to perm with possible extension

Work Location – Pleasanton, CA.

Pay: $28/hr.- $32/hr. on W2.

Job Description:

  • GLP Lab Maintenance
  • Maintain lab documentation following Standard Operating Procedures (SOP’s) to ensure GLP compliance
  • Maintain and calibrate lab equipment at required intervals to ensure GLP compliance
  • Ensure laboratory supplies are available and laboratory is a safe environment for all employees
  • Provide training or approvals for scientists (or others) to enter the GLP labs

Position Summary (Mission/Purpose):

  • You will lead and manage Good Laboratory Practice (GLP) studies as a GLP Study Director.
  • You will work directly with cross functional teams to generate quality data and documentation for business critical Regulatory submissions to the US Environmental Protection Agency (EPA).
  • Federal regulations require the use of GLP for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. These regulations require implementation of a robust quality management system to ensure the validity, integrity and reliability of data submitted for regulatory evaluation and EPA approval.
  • As GLP Study Director, you will have overall responsibility for the technical conduct of GLP studies. You would be the principal point of study control for activities related to compliance for studies, collaborating with the client's employees across Product Development, Microbiology, Toxicology, Analytical and Global Stewardship.
  • GLP Studies of responsibility include Characterization to support Microbiological and Toxicology testing, Physical Chemistry and Storage Stability/Corrosion testing.

Key Responsibilities (in descending order of importance):

  • Leads all aspects of studies to ensure data accuracy and report quality
  • Develop study protocols that meet technical, project and regulatory objectives
  • Ensure that all GLP regulations are communicated to study participants and are strictly observed
  • Work independently and collaboratively with the GLP Team to execute GLP studies, design experiments and safely complete assigned tasks in a timely manner
  • Collaboratively work with the GLP Team to maintain well organized supporting data files suitable for internal and external auditing
  • Complete final reports and archive studies per GLP guidelines
  • Ensures product availability, quality, sample transfers and tracking
  • Prepare batches with appropriate documentation and tracking for GLP studies
  • Conduct testing on batches to ensure quality and generate accurate GLP data for EPA submissions. Testing incudes (but not limited to) pH, titrations, density, physical characteristics, etc.
  • Review analytical data and prepare final study reports, taking responsibility for accuracy and compliance
  • Prepare and coordinate testing and transfer requirements with other functions

Requirements:

  • Associate’s or Bachelor's degree in Chemistry or other related Science discipline, or greater than 2 years of college courses in Chemistry or other related Science discipline
  • At least 1 year experience working in a laboratory with product formulation and/or analytical lab experience.

  • Associate Director QA

    4 weeks ago

    Oklahoma City, United States EPM Scientific Full time

    Overview: QA Leader to support the quality management systems and processes for a CRO based in Burlington. Working within pharma in both biologic development and cell and gene therapy and reporting directly to the Senior Director of Global Compliance. Role Responsibilities: Shape and expand our US quality management systems. Lead audits, ensuring GCP/GLP...

  • Associate Director of Quality Assurance

    3 weeks ago

    Oklahoma City, United States ProtaGene US, Inc Full time

    Associate Director of Quality Assurance (GCP/GLP) Massachusetts , United States Massachusetts , United States ProtaGene is a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. From research support through product CMC characterization, clinical testing, and post-market release lifecycle management and...

  • Study Director

    1 month ago

    Salt Lake City, United States Nelson Laboratories Holdings, LLC Full time

    Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Nelson Laboratories Holdings, LLC Study Director - Filter Testing in SALT LAKE CITY , Utah Job Summary: The Study Director - Filters has overall responsibility...

  • Study Director

    3 weeks ago

    Salt Lake City, United States Sotera Health Services, LLC Full time

    Job Description Job Summary: The Study Director - Filters has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time....

  • Senior Manager/Director of Quality

    1 month ago

    Long Island City, United States HistoWiz Full time

    HistoWiz is the largest online histopathology company, based in New York City. Our mission is to help biomedical researchers find cures by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving the public health. This position is accountable for the...

  • Senior Manager/Director of Quality

    1 month ago

    Long Island City, United States HistoWiz Full time

    HistoWiz is the largest online histopathology company, based in New York City. Our mission is to help biomedical researchers find cures by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving the public health. This position is accountable for the...

  • Director, Research Strategy

    2 weeks ago

    Culver City, United States Sony Pictures Entertainment, Inc. Full time

    Sony Pictures Television is looking for a strong leader to join our team as Director, Research Strategy & Analysis, supporting the Drama genre. The world’s largest independent studio, Sony Pictures Television, produces original content for linear networks and digital platforms. Our series - from dramas like THE NIGHT AGENT, THE LAST OF US, and THE BOYS, to...

  • Study Manager I

    5 days ago

    Jersey City, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionStudy ManagerA Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors'...

  • Director Research, Strategy

    2 weeks ago

    Culver City, United States Sony Pictures Entertainment, Inc. Full time

    Sony Pictures Television is looking for a strong leader to join our team as Director, Research, Strategy & Analysis supporting the Video Games and Action genres. The world’s largest independent studio, Sony Pictures Television, produces original content for linear networks and digital platforms. Our series - from dramas like THE NIGHT AGENT, THE LAST OF...

  • Director, Research, Strategy

    2 weeks ago

    Culver City, United States Sony Pictures Entertainment, Inc. Full time

    Sony Pictures Television is looking for a strong leader to join our team as Director, Research Strategy & Analysis. The world’s largest independent studio, Sony Pictures Television, produces original content for linear networks and digital platforms. Our series - from dramas like THE NIGHT AGENT, THE LAST OF US, and THE BOYS, to comedies like TWISTED METAL...

  • Toxicologist Chemist

    2 weeks ago

    Jefferson City, Missouri, United States Battelle Full time

    JOB DESCRIPTION Battelle delivers when others can't. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency. We recognize and appreciate the value and contributions of individuals...

  • Director, Research, Strategy

    6 days ago

    Culver City, United States Sony Pictures Imageworks Full time

    Sony Pictures Television is looking for a strong leader to join our team as Director, Research Strategy & Analysis. The world's largest independent studio, Sony Pictures Television, produces original content for linear networks and digital platforms. Our series - from dramas like THE NIGHT AGENT, THE LAST OF US, and THE BOYS, to comedies like TWISTED METAL...

  • Culver Military Academy Resident Director

    4 weeks ago

    Culver, United States Culver Academies Full time

    Welcome to the home of LEADERS **Mission**: Culver educates its students for leadership and responsible citizenship in society by developing and nurturing the whole individual, mind, spirit, and body, through integrated programs that emphasize the cultivation of character. Culver Academies is a private boarding school. We enroll students and employ faculty...

  • Associate Director, Translational Toxicology, Preclinical Development

    1 month ago

    Oklahoma City, United States Wave Life Sciences Full time

    Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of...

  • Senior Lab Manager(IHC)

    1 month ago

    Culver City, United States Snap Staffing Full time

    Job DescriptionJob DescriptionSenior Lab Manager(IHC)SNAPSHOT:Are you looking for an opportunity to join a cutting-edge companion diagnostics team that's developed new companion diagnostics products? THEN READ ON! Our client's technology is being harnessed and supported through a major University Research partner and the Series ‘A' funding has...

  • Director of Development, Professional Ethics

    1 month ago

    New York City, United States Fellowships at Auschwitz for the Study of Professional Ethics (FASPE) Full time

    The Director of Development is responsible for authoring and executing FASPE’s fundraising plan in concert with the CEO and active Board of Directors.   About FASPE: Launched in 2010, FASPE (Fellowships at Auschwitz for the Study of Professional Ethics) trains professional school students and practicing professionals in ethical leadership using a...

  • Telemedicine Physician- Medical Director Opportunities Available

    1 month ago

    Jersey City, United States Drs Now Full time

    Job DescriptionJob DescriptionWe are currently seeking a Telemedicine Physician- Medical Director Opportunities Available to join our team! You will focus on providing high quality patient care as part of a healthcare team.Responsibilities:Prescribe medications and treatmentsAssess patient health through interviews and physical examinationsCommunicate...

  • Director, Commercial QCA

    2 weeks ago

    Culver City, United States ImmunityBio Full time

    ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create...

  • Director, Commercial QCA

    2 weeks ago

    Culver City, United States ImmunityBio, Inc. Full time

    ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create...

  • Director, Commercial QCA

    4 weeks ago

    Culver City, United States ImmunityBio, Inc. Full time

    ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create...