Job Title: Quality Control Senior Associate/ Quality Control Associate
Location: Holly Springs, North Carolina (On-site)
Job Summary: We are seeking an experienced professional to contribute expertise in analytical testing and laboratory operations in a dynamic biopharmaceutical environment. Our team values strong technical capabilities and a rigorous approach to quality and compliance in support of manufacturing and quality control activities.
Responsibilities:
- Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.
- Review and contribute to validation documentation, ensuring accurate onboarding of laboratory equipment and computerized systems.
- Draft, revise, and review technical and quality documentation, including SOPs, test methods, technical assessments, validation reports, trend reports, and safety evaluations.
- Coordinate and execute training and method transfer activities for analytical instruments and actively participate in audits and quality initiatives.
Required:
- Bachelor’s degree or higher in Chemistry, Biochemistry, or a related scientific discipline.
- Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment with a strong background in analytical testing.
- Proficient in analytical laboratory techniques and instrumentation, including instruments such as HPLC, UPLC, TOC, and other chemistry-based platforms.
- Familiarity with laboratory systems such as LIMS, LMES/CIMS, and Trackwise, with demonstrated understanding of industry regulations, data integrity, and compliance standards.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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