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Clinical Quality Assurance Specialist

Boston, MA 02210

Posted: 02/13/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617625 Is job remote?: Yes Country: United States

Job Description

 
  • Remote Contract (EST time zone preferred) - 40 hours per week
  • Start ASAP
  A small life sciences company in the Greater Boston area is looking to add a contract Clinical QA Specialist to their team for an initial six-month period (with a high likelihood of extension). In this role, you will support the client with various GCP needs, including inspection readiness and auditing activities. Ideal candidates will have 10 years of GCP quality experience, prior experience working with MasterControl or similar systems and should be able to proactively support ongoing and upcoming audit needs. The audit volume is particularly high for a small company, so this role will be fast-paced and hands-on.

Top Skills:
  1. 10 years of GCP quality experience, with a focus on inspection readiness & auditing for GCP/QA programs.
  2. Prior experience managing audit program-related documentation in accordance with SOPs while serving as the GCP/GLP/GVP audit program administrator.
  3. Strong technical/system skills, particularly with QMS platforms like MasterControl, which requires significant administrative work.
Duties & Responsibilities:
  • Manage training (e.g., annual GCP and GLP, study-specific, product-level, and program-level training for clinical study teams) in accordance with training matrices.
  • Collaborate with and support Clinical QA team members on audit program activities (e.g., internal audits, investigator site audits, vendor audits, and Data Quality Audits).
  • Support NDA-preapproval inspection (PAI) activities as needed.
  • Assist with quality oversight of clinical programs to ensure compliance with relevant legislation and regulations.
  • Identify and escalate critical quality issues to QA management as necessary.
  • Assist with the preparation and coordination of regulatory inspections, both remotely and onsite at the company’s offices, clinical study sites, and contract service provider facilities

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.