• Serialization Specialist

    Insight Global (East Greenbush, NY)


    Job Description

    A large pharmaceutical client is looking for a skilled Serialization Specialist to join the team in Albany, NY. The ideal candidate will have at a minimum, 5 years experience in serialization or equivalent: packaging, and labeling processes, as well as an understanding of regulatory compliance and technical transfer projects. This role will involve collaboration with internal teams, external stakeholders such as CMOs (Contract Manufacturing Organizations), 3PLs (Third-Party Logistics), and EMVOs (European Medicines Verification Organizations). The Serialization Specialist will play a critical role in ensuring compliance with global regulatory requirements, supporting investigations/events, managing track-and-trace systems, and utilizing project management techniques to coordinate and execute sub-projects effectively.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

    Skills and Requirements

    • Education: Bachelor’s degree in a relevant field (e.g., Engineering, Supply Chain, Life Sciences).

    • Experience:

    • Minimum 5 years of experience in serialization, packaging, and labeling within the pharmaceutical or biotechnology industry.

    • Proven track record of supporting investigations (validations, NOEs, EOEs, DNFs, CCs, CAPAs).

    • Experience working with external stakeholders, such as CMOs, 3PLs, and EMVOs.

    • Hands-on experience with track-and-trace systems, particularly Tracelink.

    • Strong understanding of regulatory guidance, including DSCSA, EU-FMD, and ROW.

    • Involvement in technical transfer projects is highly desirable.

    • Demonstrated experience in project management, including planning, coordination, and execution of sub-projects. • Familiarity with global serialization standards and emerging regulatory requirements.

    • Experience in managing serialization projects from initiation to implementation.

    • Certification in project management (e.g., PMP, MBA) or quality systems is a plus.