Associate II, Quality Control - Sample Management
6 Months
Norwood, MA
Hourly Pay: $38.75
SHIFT: 3/2/2/3/2/2 schedule (12-hour rotating night shift, 3pm – 3am)
Job Summary
In this role, you will perform routine sample management and support various laboratory activities at manufacturing facility. This position will focus on general lab support activities. The role involves supporting the QC operations for raw materials, drug substance, drug product, and clinical chemistry, including data management and documentation.
Job Responsibilities
- Support sample management, and shipping coordination.
- Maintain lab equipment and perform housekeeping tasks.
- Write, revise, and follow SOPs, protocols, and reports.
- Ensure data entry are performed using LIMS.
- Collaborate with internal and external labs for sample coordination and testing.
- Support quality systems records, such as deviations.
- Participate in audits and continuous improvement initiatives.
- Additional duties as may be assigned from time to time
Education & Qualifications
- Education: High School Graduate or College Degree
- Experience: Science coursework with 0-2 years of experience in a GMP QC laboratory setting, focusing on molecular biology, analytical chemistry, or microbiology.
- Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP).
- Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
- Strong written and oral communication skills and organizational abilities.
- Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
