Quality Control Method Lifecycle Specialist (2nd Shift)

CamWebDir; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in West Point, PA is hiring a Quality Control Execution Support Specialist for the 2nd shift to manage end-to-end analytical method lifecycles, including new method introductions, transfers, and regulatory responses. The role emphasizes technical leadership, cross-functional collaboration, and process improvements within QC labs.

Ideal candidates have a chemistry/biology/microbiology background, 1+ year experience in analytical method intro/qualification, and strong project management and

Qualifications

• Bachelor's or Master’s in Chemistry, Biology, Microbiology or related field.
• 1+ years analytical method introduction and qualification experience in biopharmaceutical/pharmaceutical industry.

Responsibilities

• Support end-to-end method lifecycle management including transfer, validation, and tech transfer receiving lab support.
• Act as SME for regulatory questions, audits, and regulatory submissions support.
• Develop and own change controls for updates to analytical methods and compendial changes.
• Provide training to QC and Manufacturing staff on lab systems, processes and methods.

Skills

Analytical Method Development

Analytical Instrumentation

Data Analysis

Change Controls

Coaching

Regulatory Submissions

Communication Skills

Project Management

Education

Bachelor's degree in Chemistry/Biology/Microbiology

Master's degree (optional)

Tools

HPLC

cGE

ELISA

PCR

Bioassays

Job description

Merck in West Point, PA is hiring a Quality Control Execution Support Specialist for the 2nd shift to manage end-to-end analytical method lifecycles, including new method introductions, transfers, and regulatory responses. The role emphasizes technical leadership, cross-functional collaboration, and process improvements within QC labs.

Ideal candidates have a chemistry/biology/microbiology background, 1+ year experience in analytical method intro/qualification, and strong project management and