QC Method & Tech Transfer Specialist (2nd Shift)

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

Job summary

Merck & Co., Inc. in West Point, PA, seeks a Quality Control Execution Support Specialist for the 2nd shift to drive analytical method lifecycle management and support tech transfers and investigations.

The role requires expertise across separations, biochemistry, and microbiology, with training of QC site personnel. Responsibilities include cross-functional collaboration, regulatory readiness, and handling investigations with clear technical rationale.

Qualifications

• 1+ years working on analytical method introduction and qualification within biopharmaceutical/pharmaceutical industry.
• Experience with analytical methods (HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, Microbial methods, cell-based assays)
• Strong project management and stakeholder management skills
• Excellent communication and mentoring abilities
• Provide leadership for regulatory submissions and inspections

Responsibilities

• Support analytical method lifecycle management from development to validation.
• Act as SME for regulatory questions, audits, and reagent/supply issues with justification.
• Assist in transfer/tech transfer receiving lab support.
• Troubleshoot methods and equipment; perform investigations and write technical documentation.
• Train end users and site personnel on lab systems and methods.
• Lead change controls and documentation for method updates.

Skills

Analytical method development

HPLC

Regulatory coordination

Cross-functional collaboration

Problem solving

Communication skills

Coaching/Training

Analytical methods knowledge

Education

Bachelor's or Master's in Chemistry/Biology/Microbiology

Tools

Regulatory submissions

Job description

Merck & Co., Inc. in West Point, PA, seeks a Quality Control Execution Support Specialist for the 2nd shift to drive analytical method lifecycle management and support tech transfers and investigations.

The role requires expertise across separations, biochemistry, and microbiology, with training of QC site personnel. Responsibilities include cross-functional collaboration, regulatory readiness, and handling investigations with clear technical rationale.