Quality and Compliance Specialist

As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. We are partnering with an innovative digital health company committed to harnessing real-world data to support human-centered healthcare.

We are seeking a motivated and experienced Quality/Document Control/Training Specialist to join their team. This role will work closely with the Director of Compliance and may interact with other teams across the organization (ex. Clinical Operations). This role ensures effective execution of document control activities, training administration, and over-all quality support including, but not limited to, documentation and tracking of CAPA, Complaints, and Audit support.

This is a long-term, PART-TIME contract role with expected 10hrs of work/week to start. Hours may expand, but will not likely exceed 20 hours/week.

Key Skills:

Enzyme as eQMS platform

LIMS

ISO 9001 and ISO 27001

education: Bachelors

responsibilities:

• Serve as the Enzyme platform administrator - be responsible for ensuring that onboarding and offboarding occurs correctly within the system, that roles and responsibilities are correctly configured, and that training occurs in alignment with the training matrix.
• Manage the document control process by creating change order documentation and routing documents for approval upon request via Enzyme.
• Support training administration at Company by maintaining the iLMS, CITI, and Enzyme platforms and communication between those systems.
• Work with teams across the organization to facilitate study-specific training administration and document control activities.
• Support other QMS activities as needed including audits, complaints, CAPA, nonconformances, etc.
• May co-author revisions to policies and procedures as requested.

qualifications:

• 3-5 years of experience in quality management systems as applied to software development companies (e.g. software development life cycle).
• MUST HAVE experience using Enzyme as eQMS, preferably as the system administrator
• Experience using Integrated Learning Management System (iLMS)
• Experience with ISO 9001 and ISO 27001.
• Familiarity with human subjects research, HIPAA, and Good Clinical Practice (preferred).
• Experience with Google Workspace and Slack

skills: SOP, GCP (Good Clinical Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.