Drug Supply Chain Security Act (DSCSA)/Serialization Analyst

Work where you can be your best you. Join Two Labs proudly part of Envision Pharma Group, as we continue to grow our business!

Two Labs, founded in 2003, is a leading pharmaceutical services company that partners with pharma/biotech companies. At Two Labs, we understand no two product paths are alike. We deliver integrated and customized commercial solutions, helping to chart the path from clinical to commercial for a new product launch and provide strategies for continued market viability for drugs on the market.

Two Labs has a proven track record of successful launches across all major therapeutic areas with unmatched client satisfaction. Two Labs expanded its presence in the pharma consulting space both through organic growth and acquisitions. In 2020, we added the talent of CEEK Enterprises, our Strategic Consulting Team, who specializes in pharma management consultancy. Riparian – a fully integrated Professional Services firm providing consulting services, managed services, and software as a service (“SaaS”)/software solutions to the pharmaceuticals/ life sciences industry joined the Two Labs family in 2021.

Two Labs is a highly collaborative, friendly, passionate, and energized team of professionals who work in an environment that goes beyond casual dress and flex scheduling. No structure or formality is permitted to get in the way of collaboration and teamwork. The ongoing growth of the company offers team members continuous opportunities to gain experience, develop skills and chart their course along an exciting success path.

Thanks to our reputation and unique business model, Two Labs is growing, and as part of our continued growth, we're looking for dynamic and highly motivated new talent to grow and thrive right along with us.

The opportunity

As a Drug Supply Chain Security Act (DSCSA)/Serialization Data Analyst, you will help our clients maintain high-quality serialization data, regulatory compliance, and full traceability from manufacturing to delivery. Your expertise will be integral in identifying and troubleshooting serialization data issues to ensure adherence with the DSCSA and potentially other global regulations.

How will you make an impact at Envision Pharma Group?

Role responsibilities

• Monitor data quality and ensure compliance with DSCSA and global regulations.
• Maintain full traceability of units, cartons, cases, and pallets.
• Serve as the EPCIS data expert, troubleshooting reported data issues.
• Investigate and resolve serialization system discrepancies.
• Support system testing, validation, and upgrades.
• Respond to verification requests and proactively monitor systems daily.
• Assist in investigating negative responses to salable return verification requests.
• Maintain compliance documentation and serialization procedures.

Do you have what we're looking for?

Education & Experience

• Bachelor's degree or equivalent experience.
• 3+ years of experience in serialization business processes.
• Life sciences, biotech, or regulated industry experience.
• Knowledge of Good Manufacturing Practice (GMP) & Good Documentation Practice (GDP).
• Experience with process improvement initiatives

Technical Skills

• Experience with Serialization Systems: TraceLink, Rfxcel, LSPEDIA, Systech, SAP ATTP, etc.
• Strong knowledge of GS1 Serialization Data Standards.
• Data analysis and problem-solving skills.

Soft Skills

• Strong interpersonal and communication skills.
• Ability to navigate complexity in a matrixed business environment.
• Action-oriented with attention to detail and accuracy.
• Ability to influence stakeholders and work collaboratively.

At EPG, the provided salary range reflects the potential base salary for this role in the United States, considering factors like your professional and academic experience, training, and role responsibilities. In addition to a competitive base salary, we offer an attractive total compensation package designed to reward and support our people.

#TogetherWeDiscover

We turn vision into reality. Our people are integral to our success and our values reflect the Envision philosophy where our teamwork helps us all grow and our enthusiasm inspires each other.

Our Envisionary culture is a special environment that gives every employee a voice the space to invent and the chance to excel. A place where, every day, people laugh, think, take risks, and are excited about the possibilities the day brings.

Explore your place at Envision. If you have the experience highlighted above, we would love to hear from you!