R&D Partners · 4 hours ago
Quality Assurance Specialist
Holly Springs, NC
Contract
Onsite
Senior Level
$79K/yr - $89K/yr
5+ years expR&D Partners is a global functional service provider specializing in scientific, clinical research, and engineering. They are seeking a Quality Assurance Associate responsible for ensuring compliance with regulatory requirements and internal guidelines related to product release.
Staffing Agency
Hiring Manager
Angelique Dela Cruz, CHRA
Responsibilities
Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements
Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
Authors, reviews, and QA approves Standard Operating Procedures (SOP’s), protocols/reports, work instructions, etc
Qualification
Required
Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements
Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
Authors, reviews, and QA approves Standard Operating Procedures (SOP's), protocols/reports, work instructions, etc
Must have familiarity with SAP; strong preference for candidates who have used SAP for batch release in a prior role
5 years' related experience in Pharma Quality
Strong organization, administrative and data entry skills
Preferred
Experience using Veeva and/or GLIMS – Nice To Have
Benefits
Medical insurance – PPO, HMO &
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Company
R&D Partners
R&D Partners is a national staffing agency that specializes in scientific, clinical, and engineering positions.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-06-01Acquired
Leadership Team
Pooja Pathak
R&D Partners Research Scientist at Bristol Myers Squibb
Scott Hopkins
Founder and Member of Board of Directors
Company data provided by crunchbase