Tundra Technical Solutions · 3 days ago
Sr Quality Systems & Compliance Specialist
Cambridge, MA
Contract
Hybrid
Mid, Senior Level
$55/hr - $60/hr
4+ years expTundra Technical Solutions is seeking an experienced Senior Quality Systems & Compliance Specialist to support Quality Systems and Compliance activities within a regulated pharmaceutical environment. This role focuses on product complaint management, quality documentation, and inspection readiness, collaborating with internal teams and external partners.
EmploymentRecruitingStaffing Agency
Hiring Manager
Kasey Paxton SHRM-CP
Responsibilities
Manage intake of product complaints via a secure mailbox
Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates, and Drug Safety/Pharmacovigilance
Assist with preparation of product complaint metrics and reports
Develop and support training related to product complaint handling
Support revisions and updates to product complaint SOPs and work instructions
Archive product complaints in accordance with internal policies
Support document control activities, including archival
Assist with regulatory inspection preparation and provide onsite support during inspections as needed
Support events and actions teams with daily tasks and follow-ups
Collaborate across Quality, Regulatory, and Safety functions to ensure compliance with GxP requirements
Qualification
Required
Prior experience with product complaint and/or adverse event processes, including intake and reconciliation
Strong working knowledge of GxP regulations, including product complaint handling, patient privacy principles, and document control
Bachelor's degree in Life Sciences, Chemistry, Engineering, or equivalent
Minimum 4 years of experience in Pharmaceutical Quality or Regulatory functions
Preferred
Experience with Veeva QualityDocs and/or Veeva eQMS is a plus
Company
Tundra Technical Solutions
Tundra Technical Solutions is providing innovative staffing solutions and services as a strategic partner to the client and candidate.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John McNish
Chief Operating Officer
Recent News
2023-12-26
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