Analytical QC Method Lifecycle Specialist - 2nd Shift

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

Benefits offered by this job

Annual bonus

401(k) plan

Medical insurance

Paid time off

Job summary

HireLifeScience is hiring a Quality Control Execution Support Specialist (2nd shift) to manage analytical method lifecycles and support transfers, validations, investigations, and tech rationale. This role requires collaboration with QC and Manufacturing and focuses on separations, biochemistry, and microbiology.

The position demands on-site, 5-day-a-week support for QC labs, with opportunities to influence regulatory readiness and audits through strong technical documentation and

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology or related field.
• 1+ years on analytical method introduction and qualification in biopharma/pharma.
• Experience with HPLC, ELISA, PCR and microbial methods.

Responsibilities

• Support end-to-end lifecycle of analytical methods and tech transfers.
• Provide SME assessment for method/equipment qualification and investigations.
• Train end users and support regulatory responses.
• Lead change controls and lifecycle management of methods.
• Perform analytical method troubleshooting and cross-functional reviews.

Skills

Analytical Method

Analytical Thinking

Change Management

GMP Compliance

Laboratory Documentation

Data Analysis

Problem Solving

Communication Skills

Education

Bachelor's degree in Chemistry/Biology/Microbiology

Tools

HPLC

cGE

ELISA

Bioassays

PCR

Microbial methods

Job description

HireLifeScience is hiring a Quality Control Execution Support Specialist (2nd shift) to manage analytical method lifecycles and support transfers, validations, investigations, and tech rationale. This role requires collaboration with QC and Manufacturing and focuses on separations, biochemistry, and microbiology.

The position demands on-site, 5-day-a-week support for QC labs, with opportunities to influence regulatory readiness and audits through strong technical documentation and