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.

Top 3 Must Have Skill Sets:

• GMP experience either in QC or manufacturing operations.
• Have worked in sample management or have sample management experience related to QC and/or manufacturing
• Team player and eager to learn and collaborate

Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.