Quality Engineer optimizing information structures and documentation processes in regulatory environment. Ensuring compliance and operational efficiency throughout product lifecycle.
BG
Hybrid Quality Assurance Manager, Finished Goods
Posted 27 minutes ago
About the role
- 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)
Benefits
- Contract position, **40 hours per week**
- Hybrid schedule: **2 days onsite**
- Minimal travel to manufacturing sites as needed
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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