Sr Associate I, Quality Control (Drug Product)

Role Summary

Senior Associate I, Quality Control (Drug Product) responsible for ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release.

Responsibilities

• Perform and review analytical testing for product release, stability studies, and method validation.
• Lead method transfer and qualification activities.
• Author protocols, technical reports, and change controls.
• Mentor peers and contribute to cross-functional process improvement initiatives.
• Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations).
• Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed.
• Evaluate the impact of QC activities on project teams, including implications for batch release and stability data.
• Support setting and reporting of measurable goals, targets, and mitigation plans.
• Represent QC during audits, inspections, and site-wide initiatives.

Qualifications

• Bachelor‚Äôs degree from an accredited college or university (preferred STEM discipline).
• Minimum of 4 years of relevant experience within Quality Control in a biotech or pharmaceutical environment.
• Demonstrated expertise with LC-MS instrumentation and analysis.
• Experience using acquisition/data collection systems.
• Ability to manage tasks across multiple timelines and meet deadlines, including when priorities conflict.
• Experience presenting information and collaborating with cross-functional or interdepartmental teams.
• Strong oral and written communication skills for interdepartmental coordination.
• Experience providing guidance, mentorship, or training to colleagues.
• Strong knowledge of cGMP requirements and regulatory compliance standards.

Skills

• LC-MS instrumentation expertise
• Analytical testing and method validation
• Cross-functional collaboration
• Documentation and report writing
• Problem-solving and escalation
• Data analysis and interpretation

Education

• Bachelor‚Äôs degree in a STEM discipline (preferred)
• Master‚Äôs degree in a STEM discipline (highly desired)

Additional Requirements

• None specified beyond the above qualifications.