Quality Control Senior Associate

Quality Control Sr. Associate

The Quality Control Sr. Associate supports QC Sample Management and Stability team within the QC Support organization. The Sr. Associate will be responsible for the receipt, handling, tracking, storage, and disposal of samples used in analytical testing, while ensuring compliance with internal SOPs, regulatory requirements, and good documentation practices. The Sr. Associate will collaborate closely with laboratory analysts, Quality Assurance, and other cross-functional teams to maintain efficient and accurate testing workflows.

Key Responsibilities:

• Maintain required chain of custody of incoming samples in the Laboratory Information Management System (LIMS).
• Ensure proper labeling, storage, and chain-of-custody documentation for all samples.
• Evaluate and Document Results: Accurately record data, assess results for compliance with specifications, and ensure documentation meets GDP and GMP requirements.
• Troubleshoot and Resolve Issues: Identify technical and compliance issues within QC, and escalate or resolve them using defined procedures; collaborate with senior staff for complex problems.
• Support Investigations and Audits: Participate in laboratory investigations related to out-of-specification results or deviations; provide supporting documentation during audits.
• Cross-Functional Collaboration: Work closely with analysts and team leads across QC areas to meet project milestones and testing timelines.
• Continuous Improvement: Suggest process improvements and contribute to efficiency initiatives within QC labs.
• Compliance and Safety: Adhere to all safety guidelines, SOPs, and regulatory requirements while performing testing and handling hazardous materials.

Qualifications:

• Bachelor's degree preferred.
• 3–5 years of experience in a laboratory or sample management role.
• Familiarity with LIMS or other sample tracking systems preferred.
• Strong attention to detail and organizational skills.
• Ability to work in a fast-paced, regulated environment.
• Good communication and teamwork skills.
• Available to work on a 4/10 schedule (7:30am - 6pm), Wednesday through Saturday, schedule.