Quality Assurance Manager, Finished Goods
BioPharma Consulting JAD Group
contract
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancefinished goods packaginglabelingroot cause analysiscorrective actionspreventive actionsdeviations managementCAPAschange controlscontinuous improvement
Soft Skills
organizational skillsinterpersonal skillscommunication skillsleadership