R&D Partners · 8 hours ago
Quality Assurance Manager
Cambridge, MA
Contract
Onsite
Senior Level
$150K/yr - $166K/yr
5+ years expR&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. They are seeking a Quality Assurance Manager to oversee quality operations for finished goods and external manufacturing partners, ensuring compliance with internal and regulatory standards.
Staffing Agency
Responsibilities
Serve as QA representative for commercial finished goods and external manufacturing partners
Represent Finished Goods Quality Operations at routine internal meetings and external contract manufacturers and for commercial production
Oversee quality aspects of commercial finished goods specifications, qualification and validation, drawings, artwork, label, serialization, and packaging operations at CMOs for global commercial supply and ensure compliance to internal standards and regulatory requirements for US production
Review and approval of content within manufacturing partner and Alnylam Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data
Manage Quality Records (deviation, capa, change control, serialization excursions, issue escalation) as it relates to commercial finished good assembly, label, and packaging activities
Qualification
Required
Minimum BS degree in life sciences, engineering, or related field
A minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company
Experience with finished goods assembly, labeling, and packaging manufacturing operations at external manufacturers
Experience leading, training, and/or implementing root cause analysis and effective investigation practices
Benefits
Medical insurance – PPO, HMO & HSA
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
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