Senior Quality and Compliance Specialist

1 month ago

Seattle, United States MMS Full time
Job DescriptionJob Description

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Specific Skills:

  • Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
  • Understanding of how to plan, prepare and conduct GCP audits independently.
  • Proficient in authoring and managing audit documents independently.
  • Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
  • Develop CAPA plans and contribute to resolution of audit findings independently.
  • Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
  • Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
  • Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada.
Requirements:
  • College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
  • Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
  • Expert knowledge of scientific principles and concepts. 
  • Reputation as emerging leader in field with sustained performance and accomplishment.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Proficient with 21 CFR Part 11, FDA, and GxP requirements.
  • Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.

Powered by JazzHR

4xizNoUoyp

  • Grant and Contract Compliance Specialist

    4 weeks ago

    Seattle, United States The Salvation Army Northwest Division Full time

    The Salvation Army Northwest Division Grant and Contract Compliance Specialist West Seattle , Washington Apply Now DescriptionDEPARTMENT: Program: Social ServicesPOSITION TITLE: Grant and Contract Compliance SpecialistSTATUS: Regular Full-Time / Non-ExemptPAY: $33.65/hourJob ScopeThe Grant and Contract Compliance Specialist is responsible for providing the...

  • Grant and Contract Compliance Specialist

    1 month ago

    Seattle, United States The Salvation Army Northwest Division Full time

    Description DEPARTMENT: Program: Social Services POSITION TITLE: Grant and Contract Compliance Specialist STATUS: Regular Full-Time / Non-Exempt PAY: $33.65/hour Job Scope The Grant and Contract Compliance Specialist is responsible for providing the Northwest Division with grant management and compliance support to ensure our portfolio of projects is...

  • Grant and Contract Compliance Specialist

    4 weeks ago

    Seattle, United States The Salvation Army Northwest Division Full time

    The Salvation Army Northwest Division Grant and Contract Compliance Specialist West Seattle , Washington Apply Now DescriptionDEPARTMENT: Program: Social ServicesPOSITION TITLE: Grant and Contract Compliance SpecialistSTATUS: Regular Full-Time / Non-ExemptPAY: $33.65/hourJob ScopeThe Grant and Contract Compliance Specialist is responsible for providing the...

  • Compliance Specialist

    2 days ago

    Seattle, United States Coast Property Management Full time

    About You: You are thoughtful, deliberate, and precise, with an eye for managing detail-work and always following through. While you are friendly and helpful to others, you can also work quietly and diligently on your own. You bring accountability to work, achieving goals consistently and efficiently. Are you our next Compliance Specialist? A somewhat...

  • Compliance Specialist

    1 month ago

    Seattle, United States Human Good Full time

    This position develops, monitors, and maintains HUD and Tax Credit and other regulatory occupancy compliance at the affordable housing communities under the supervision of the Senior Compliance Specialist and Director of Compliance. * Perform file audits of resident initial certifications, re-certifications and/or interim reviews; Review and audit all...

  • Compliance Specialist

    4 weeks ago

    Seattle, United States Human Good Full time

    This position develops, monitors, and maintains HUD and Tax Credit and other regulatory occupancy compliance at the affordable housing communities under the supervision of the Senior Compliance Specialist and Director of Compliance. * Perform file audits of resident initial certifications, re-certifications and/or interim reviews; Review and audit all...

  • Grant and Contract Compliance Specialist

    1 month ago

    Seattle, United States The Salvation Army USA Western Territory Full time

    Description DEPARTMENT: Program: Social Services POSITION TITLE: Grant and Contract Compliance Specialist STATUS: Regular Full-Time / Non-Exempt PAY: $33.65/hour Job Scope The Grant and Contract Compliance Specialist is responsible for providing the Northwest Division with grant management and compliance support to ensure our portfolio of projects is...

  • Grant and Contract Compliance Specialist

    1 month ago

    Seattle, United States Salvation Army Full time

    DEPARTMENT: Program: Social Services POSITION TITLE:Grant and Contract Compliance Specialist STATUS: Regular Full-Time / Non-Exempt PAY: $33.65/hour Job Scope The Grant and Contract Compliance Specialist is responsible for providing the Northwest Division with grant management and compliance support to ensure our portfolio of projects is effectively...

  • Grant and Contract Compliance Specialist

    4 weeks ago

    Seattle, United States Salvation Army Full time

    DEPARTMENT: Program: Social Services POSITION TITLE:Grant and Contract Compliance Specialist STATUS: Regular Full-Time / Non-Exempt PAY: $33.65/hour Job Scope The Grant and Contract Compliance Specialist is responsible for providing the Northwest Division with grant management and compliance support to ensure our portfolio of projects is effectively...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Seattle, United States Hobson Associates Full time

    Job Title: Senior Regulatory Affairs Specialist Location: Greater Seattle Area (Hybrid Role, Three Days In-Office) Our client is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in the Seattle Area. The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and...

  • Trade Compliance Specialist

    3 weeks ago

    Seattle, United States Bee Talent Solutions Full time

    Job DescriptionJob DescriptionThis role is responsible for the development of international content to support our client's Trade Compliance tools which provide compliance requirements for assisting customers manage their import and export compliance requirements. This will encompass areas of trade to include eCommerce, business-to-business, and...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Seattle, Washington, United States Hobson Associates Full time

    Job Title: Senior Regulatory Affairs SpecialistLocation: Greater Seattle Area (Hybrid Role, Three Days In-Office)Our client is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in the Seattle Area.The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and...

  • Compliance Specialist

    1 month ago

    Seattle, United States humangood Full time

    Job Details Description This position develops, monitors, and maintains HUD and Tax Credit and other regulatory occupancy compliance at the affordable housing communities under the supervision of the Senior Compliance Specialist and Director of Compliance. Perform file audits of resident initial certifications, re-certifications and/or...

  • Compliance Specialist

    4 weeks ago

    Seattle, United States humangood Full time

    Job Details Description This position develops, monitors, and maintains HUD and Tax Credit and other regulatory occupancy compliance at the affordable housing communities under the supervision of the Senior Compliance Specialist and Director of Compliance. Perform file audits of resident initial certifications, re-certifications and/or...

  • Principal Environmental Compliance Specialist

    4 weeks ago

    Seattle, United States LVI Associates Full time

    We are seeking a highly skilled Principal Environmental Compliance Specialist to join the team in Seattle, WA of a West Coast based employee-owned environmental consulting firm. The ideal candidate will lead our environmental compliance efforts, ensuring that our clients meet regulatory requirements and uphold environmental standards. This role offers the...

  • Senior Compliance Analyst

    1 week ago

    Seattle, United States The Boeing Company Full time

    Establish and maintain ground operations procedures. Regularly review the ground operations procedures, manuals, service guidance, and command media which have impact on the performance of aircraft ground operations. Perform compliance assessments of Compliance Analyst, Operations, Compliance, Analyst, Senior, Technology

  • Compliance Specialist 2

    3 days ago

    Seattle, United States King County Regional Homelessness Authority Full time

    Job DescriptionJob DescriptionSalary: $37.14 - $50.48 Hourly DOETitle: Compliance Specialist 2Salary Range: $37.14 - $50.48 HourlyClassification: Full-time; Non-Exempt; Represented by Protec17Location: Seattle, WA; HybridOrganizational Overview The King County Regional Homelessness Authority (KCRHA) is an administrative agency that oversees...

  • Compliance Specialist 1

    2 days ago

    Seattle, United States King County Regional Homelessness Authority Full time

    Job DescriptionJob DescriptionSalary: $36.06 - $47.12 Hourly DOETitle: Compliance Specialist 1Salary Range: $36.06 - $47.12 HourlyClassification: Full-time; Non-Exempt; Represented by Protec17Location: Seattle, WA; HybridOrganizational Overview The King County Regional Homelessness Authority (KCRHA) is an administrative agency that oversees...

  • Senior Living Referral Specialist

    3 weeks ago

    Seattle, United States Always Best Care Senior Services Full time

    Job DescriptionJob DescriptionThe Senior Living Referral Specialist reports to the agency Owner/Administrator and plays a pivotal role in the success of our business. This individual is responsible for continuing to grow our client base by establishing and maintaining trusting relationships that will develop into referrals of in-home care and assisted living...

  • Senior Living Referral Specialist

    4 weeks ago

    Seattle, United States Always Best Care Senior Services Full time

    Job DescriptionJob DescriptionThe Senior Living Referral Specialist reports to the agency Owner/Administrator and plays a pivotal role in the success of our business. This individual is responsible for continuing to grow our client base by establishing and maintaining trusting relationships that will develop into referrals of in-home care and assisted living...