Quality Associate - Remote Position

Clinical Quality Assurance · Santa Cruz, California
Department Clinical Quality Assurance
Employment Type Full-Time
Minimum Experience Experienced

About MAPS Public Benefit Corporation (MAPS PBC):

MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, psychedelic therapist training programs, and in the future - sales of prescription psychedelics. We prioritize patient and public benefit above profits. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit.  More information about the organization is available at mapspublicbenefit.com.

 

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing. 

 

MAPS PBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS PBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

 

Position Summary:

MAPS PBC is seeking a driven professional to support quality initiatives as a part of the Department of Clinical Quality Assurance. Reporting to the Director, GxP Quality Assurance (DQA) with dotted line reporting to the Manager, Clinical Quality Assurance (MCQA), the Quality Associate (QA) will execute assigned Quality Assurance tasks that not only support implementation of the MAPS PBC Quality System but also assure that all MAPS-sponsored clinical research is conducted according to applicable regulatory requirements, MAPS PBC documented policies and processes, and industry standards. This includes conduct of assigned investigator site compliance visits/audits and advise assigned sites on remedial actions. Additionally, the QA may assist in or perform audits of relevant clinical research documentation, databases, trial master files, etc., as assigned. As needed, the QA will also support the MCQA by executing assigned tasks and projects related to document control, training, CAPA management, and other applicable Quality Assurance areas. This could include but is not limited to SOP writing or review, project tracking activities, and training administration. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational skills, and the ability to maintain a positive outlook while motivating internal and clinical site staff for inspection readiness.

 

Location:

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet video meetings. Certain home office expenses may be reimbursed. A work computer is provided. The MAPS PBC headquarters office is located in Santa Cruz, CA. This position requires up to 75% travel.

 

Hours:  Full-time, 40 hours per week.We are a West Coast-based company and applicants must be available during normal business hours

(9:00 AM - 6:00 PM Pacific Time, Monday through Friday). The exact schedule may be arranged upon hire. Occasional nights and weekend hours may be required with advance arrangement. 

 

Requirements:

  • Bachelor’s Degree in a business or scientific field 
  • 2+ years’ direct experience in clinical quality assurance or 2+ years’ direct experience in Clinical Research and Development, preferably as a Study Monitor
  • Familiarity with global GCP regulatory requirements and Good Documentation Practices  
  • Demonstrated communication and technical writing skills 
  • Strong computer and analytical thinking skills; must be detailed oriented
  • Goal-oriented, self-starter with proven ability to work independently
  • Clinical Research/Operations experience, particularly related to investigator site monitoring
  • Basic knowledge of Quality Assurance concepts
  • Familiarity with Standard Operating Procedures and their purpose
  • Proficiency in MS Word and Excel; MS Word formatting experience is desired
  • Excellent written and verbal communication skills
  • Strong desire and interest in learning new skills
  • Patience and attention to detail
  • Ability to work independently and within a team
  • Self-motivating, able to prioritize and take initiative 
  • Strong organizational skills with attention to details and timelines 
  • Able to work quickly in a remote virtual setting 

 

Responsibilities:

The QA performs the following duties:  

  • After completing an auditing training program, conducts compliance visits/audits of assigned investigator sites following the MAPS PBC Annual Audit Schedule. This includes conduct of the audit and generating a report that includes recommendations for remediation of issues identified, if applicable.
  • Serves as primary QA Contact for assigned studies and/or investigator sites  
  • Serves as QA Advisor and manager to assigned investigator site staff as they remediate issues
  • Tracks completion of investigator site remediations and closure of associated CAPAs.
  • Assists SMEs in writing assigned SOPs, as required.
  • Assists the MCQA by completing assigned tasks related to training, CAPA management, and general document management as well as activities related to tracking compliance and generation of Quality System metrics.
  • As needed, assists with vendor qualification and ongoing audits, and related activities
  • Supports the DQA as needed, to ensure execution of the MAPS PBC Audit Program
  • Executes other assigned tasks related to regulatory compliance, inspection readiness and quality systems 

 

Additional Competencies:

  • Communicates and collaborates with MAPS staff, investigator site staff, and other stakeholders
  • Checks in regularly with supervisor and complete assignments by agreed deadline
  • Proactively seeks methods of improvement, streamlining workflows and building efficiencies in individual work and project outcomes
  • Confident and influential approach 
  • Coordination and planning of tasks and time management 
  • Able to recognize potential obstacles and work within set timelines 
  • Conscientious and precise delivery of work even when under pressure 
  • Experience with health authority audit support, Pharmacovigilance systems, Standard Operating Procedure (SOP) development, document control, and/or Learning Management Systems (LMS) is a plus 

 

FLSA Status: Exempt/salaried

 

Compensation:  Salary available upon request. Includes full benefits

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  • Location
    Santa Cruz, California
  • Department
    Clinical Quality Assurance
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced