Associate, Internal Quality Control Operations

Eli Lilly and Company • Boston, MA

1d • $71,250 - $161,700 • Hybrid

About The Position

The Associate, Internal Quality Control Operations will report to the Director of Quality Control and will be located on site (4 days a week) at 201 Brookline Ave Boston, Ma. The role will support cGMP analytical testing of various gene therapy products. As a Quality Control Associate, you will be responsible for overseeing and maintaining the integrity of our products and processes. In this role, you will assist a team of quality control specialists to ensure that all products meet both internal standards and industry regulations. You will collaborate closely with production, QA, and supplier teams to ensure prompt release of testing data to support clinical material, investigate non-conformances, and drive corrective actions. You will perform analytical testing, lead investigations, qualifications and validations of methods, and review data generated in the lab.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related scientific field
• Minimum of 10 years of experience in Quality Control or a CMC environment within the pharmaceutical or biotechnology industry, with at least 2 years in a leadership or management role
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 210/211), ICH guidelines, and other relevant global quality standards.
• Proven experience with analytical techniques such as NGS, ELISA, Cell-based potency, PCR, and cell culture.
• Demonstrated ability to lead and motivate a team, with strong interpersonal and communication skills.
• Excellent problem-solving, analytical, and decision-making abilities.
• Experience with LIMS (Laboratory Information Management System) and other quality management software.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Perform analytical testing of release and stability products in the QC laboratory.
• Train QC analysts on analytical methods, investigation writing, certificate of analyses creation and review, method qualification and various high level QC processes.
• Create and lead a certified trainer process wining QC.
• Lead review of laboratory logbooks.
• Develop, implement, and maintain robust quality control procedures, specifications, and testing methodologies for various products.
• Ensure all QC activities align with cGMP, FDA regulations, ICH guidelines, and other applicable global regulatory standards.
• Lead investigations into out-of-specification (OOS) and out-of-trend (OOT) results, identifying root causes and implementing effective corrective and preventive actions (CAPAs).
• Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and R&D teams to optimize processes and resolve quality-related issues.
• Prepare and review QC documentation, including protocols, reports, and standard operating procedures (SOPs).
• Engage in internal and external audits, providing expert support and responding to audit observations.
• Drive continuous improvement initiatives within the QC operations to enhance efficiency, accuracy, and compliance.
• Mentor, train, and develop a high-performing team of QC professionals.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior