Sr. Associate, Serialization and Packaging
$103,500–$133,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Execute commercial packaging, labeling, and serialization activities at the Framingham facility, performing equipment setup, line clearance, troubleshooting, and shutdown while ensuring compliance with cGMP and GDP. Serve as the primary operational resource for Antares equipment and TraceLink platforms, managing commissioning, aggregation, reconciliation, and exception management alongside Oracle transaction support. Complete and review batch records, forms, and logbooks for inspection readiness, while investigating deviations, CAPAs, and system discrepancies. Provide day-to-day technical guidance to operational personnel, lead continuous improvement initiatives, and support training on SOPs and equipment. Maintain documentation accuracy and inspection readiness for internal audits and regulatory reviews.
Required Qualifications
- 2–4 years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment
- Experience supporting commercial-stage pharmaceutical products
- Experience operating within an in-house packaging and serialization environment
- Experience with DSCSA compliance and serialization regulations
- Experience training and mentoring manufacturing or supply chain personnel
- Experience working with Antares serialization equipment or similar systems
- Experience using TraceLink or equivalent serialization management platforms
- Working knowledge of Oracle ERP transactions within operations environment
- Strong understanding of cGMP, GDP, and Good Documentation Practices
Desired Qualifications
- Associates Degree, Biotechnology Certificate, or Bachelor's Degree in Life Sciences, Engineering, Supply Chain, or related discipline preferred
- High School Diploma or GED with relevant pharmaceutical or biotechnology industry experience may be considered
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