Quality Senior Specialist - Finished Goods – Commercial (Contract) 29636
$114,400–$135,200 year
On-siteBoston, Massachusetts, United States
Job Summary
Review validation documentation, executed batch records, and master batch records for external contract manufacturing organizations to ensure appropriate documentation and batch release. Resolve comments with CMOs, approve investigations, CAPAs, and change controls, and support the daily management of lot disposition processes. Maintain quality system files for easy retrieval and assist with monthly or quarterly metrics reporting. This contract role requires a Bachelor's degree in a scientific field and 3+ years of experience with finished goods, packaging, or labelling validation. Compensation ranges from $55-$65/hr, with eligibility for overtime pay. The position is with a third-party agency partner on assignment at Vertex Pharmaceuticals, focusing on commercial validation across multiple global markets.
Required Qualifications
- Bachelor's degree in a scientific, engineering, or allied health field
- 3+ years of relevant work experience
- Experience with Finished Goods/Packaging/Labelling
- Strong attention to detail
- Self-motivated
- Independent
- Organized
- Effective communicator
- Ability to navigate a fast-paced work environment
Desired Qualifications
- Experience with Commercial Validation (especially packaging validation) preferred
- Small molecule primary & secondary packaging validation and product launch experience in the following markets: US, CA, EU/UK, AU, CH, IL, BR & RU
- Technical experience and engineering background
- Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines
- Effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
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