QA Manager, Finished Goods - Contract - Cambridge, MA
Join our client in this QA manager role and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail, this could be your perfect opportunity.
Proclinical is seeking a QA Manager to support commercial finished goods and external manufacturing operations.
Primary Responsibilities:
In this role, you will focus on ensuring compliance with internal standards and regulatory requirements for global commercial supply. This position involves collaboration with internal teams and external contract manufacturers, with an emphasis on quality oversight of specifications, packaging, labelling, and serialization processes.
Skills & Requirements:
- 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.
The QA Manager's responsibilities will be:
- 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.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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