GMP Lab Operations & Sample Management Specialist

Actalent; Cambridge (MA); Vor Ort; USD 50.000 - 58.000; Vollzeit

Benefits dieser Stelle

PTO 15 days to start

10–12 paid holidays per year

401(k) with 3.5% company match

Zusammenfassung

Actalent is seeking a detail-oriented Sample Management & Laboratory Operations Associate to support GMP-regulated lab and manufacturing workflows in Cambridge, MA. You will manage samples, coordinate inventory, move materials, and document activities in ERP and quality systems, ensuring SOP and quality compliance.

You will collaborate with lab, manufacturing, and quality teams, enter data accurately, and help maintain cleanroom and containment practices while supporting audits and continuous

Qualifikationen

• High School Diploma or Associate Degree required.
• Minimum of 4 years of experience in a GMP or cGMP-regulated environment.
• Experience with sample management, sample receiving, accessioning, or laboratory operations.
• Strong data entry and documentation skills with a high level of accuracy.
• Proficiency in Microsoft Excel and electronic data management systems.
• Experience using ERP systems and quality management systems.
• Ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail.

Aufgaben

• Support sample management activities across multiple departments in accordance with GMP guidelines and SOPs.
• Receive, accession, track, and organize samples while maintaining accurate documentation and chain-of-custody records.
• Enter and maintain sample information within ERP and quality management systems.
• Assist with laboratory operations, including material handling, inventory management, and media preparation activities.
• Transport materials, samples, and supplies across lab and manufacturing areas as needed.
• Perform biopsy accessioning and related documentation activities.
• Support cleanroom operations, including gowning procedures and adherence to contamination-control practices.
• Maintain accurate records using Excel and other electronic systems.
• Monitor inventory levels and assist with inventory control activities utilizing ERP systems and RF scanning equipment.
• Collaborate with laboratory, manufacturing, and quality teams to ensure efficient workflow and compliance.

Kenntnisse

Data entry

Documentation

Prioritization

Attention to detail

Ausbildung

High School Diploma or Associate Degree

Tools

ERP systems

Quality management systems

Jobbeschreibung

Actalent is seeking a detail-oriented Sample Management & Laboratory Operations Associate to support GMP-regulated lab and manufacturing workflows in Cambridge, MA. You will manage samples, coordinate inventory, move materials, and document activities in ERP and quality systems, ensuring SOP and quality compliance.

You will collaborate with lab, manufacturing, and quality teams, enter data accurately, and help maintain cleanroom and containment practices while supporting audits and continuous