Quality Assurance Manager responsible for quality assurance of finished goods and external manufacturing partners. Leading quality assurance activities, documentation management, and continuous improvement.
Responsibilities
Serve as QA representative for commercial finished goods and external manufacturing partners
Oversee quality aspects of finished goods, including:
Specifications
Qualification and validation activities
Drawings, artwork, labels, serialization, and packaging operations
Review and approve manufacturing partner documentation, including:
Bills of Materials (BOMs)
Manufacturing and Packaging Records (MPRs)
Product specifications and variable data
Ensure proper archival and maintenance of manufacturing partner documentation within electronic quality systems
Manage and approve quality records such as deviations, CAPAs, change controls, and issue escalations
Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions
Identify and recommend continuous improvement opportunities to reduce current and future quality risks
Collaborate effectively with internal stakeholders and external manufacturing partners
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related field
Minimum of **5 years of experience** in:
Finished goods packaging and labeling
QA oversight of external manufacturing partners
Direct experience supporting commercial finished goods operations
Strong organizational, interpersonal, and communication skills
Proven experience leading investigations and implementing corrective actions
Proficiency with electronic quality systems (e.g., Veeva or similar platforms)
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