Quality Assurance Manager, Finished Goods

Overview

Title:

Quality Assurance Manager, Finished Goods

Job

Location:

Cambridge, MA (Hybrid: 3 days/wk remote)

Duration: 06 months contract (+Possibility of extension)

• 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 Clients Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data.
• Ensure proper archival of manufacturing partner documentation in Clients document management system.
• Manage Quality Records (deviation, CAPA, change control, serialization excursions, issue escalation) as it relates to commercial finished good assembly, label, and packaging activities.
• Recommend continuous improvement opportunities on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.

• 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.
• Excellent organizational, communication (written and verbal), and interpersonal skills. Experience leading, training, and/or implementing root cause analysis and effective investigation practices.