Proclinical Staffing · 5 hours ago
QA Manager, Finished Goods
Cambridge, MA
Full-time
Onsite
Mid Level
$65/hr - $75/hrProclinical Staffing is seeking a QA Manager to support commercial finished goods and external manufacturing operations. The role focuses on ensuring compliance with internal standards and regulatory requirements for global commercial supply, involving collaboration with internal teams and external contract manufacturers.
Staffing & Recruiting
Hiring Manager
Shannon Briggs
Responsibilities
Act as the QA representative for commercial finished goods and external manufacturing partners
Represent Finished Goods Quality Operations in internal meetings and with external contract manufacturers during commercial production
Oversee quality aspects of specifications qualification, validation drawings, artwork, labels, serialization, and packaging operations for global commercial supply
Manage and review Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data
Ensure proper documentation archival within the document management system
Handle Quality Records such as deviations, CAPAs, change controls, serialization excursions, and issue escalations related to finished goods assembly, labeling, and packaging activities
Identify and recommend continuous improvement opportunities to mitigate risks and enhance operational effectiveness
Qualification
Required
Degree in life sciences, engineering, or a related field
Experience in pharmaceutical or biopharmaceutical industries, particularly in finished goods assembly, labeling, and packaging operations at external manufacturers
Strong organizational, communication (written and verbal), and interpersonal skills
Familiarity with training, root cause analysis, and effective investigation practices
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
Founded in 2005
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase