Senior QC Analyst - Method Transfers & CAPA (Contract)

Proclinical Group; Town of Mansfield (NY); On-site; USD 76,000 - 94,000; Full time

Job summary

Proclinical is seeking an Analyst IV for Quality Control Technical Services to support quality and compliance efforts from development through commercialization. This contract-based role based in Boston, MA requires a strong foundation in GMP QC and analytical method transfer.

You will contribute to stability studies, data trending, investigations, CAPAs, and cross-functional collaboration with CMC Development, Manufacturing, Regulatory, and QA.

Qualifications

• Background in chemistry, biology, biochemistry, or a related scientific field.

Responsibilities

• Support the development and justification of technical specifications for raw materials, intermediates, and finished products.
• Facilitate the transfer and implementation of analytical methods, including validation and training of laboratory personnel.
• Execute and document stability studies to determine product shelf life and ensure regulatory compliance.
• Analyze and trend QC data to identify and address potential quality issues using statistical tools.
• Investigate quality deviations, perform root cause analysis, and implement corrective and preventive actions (CAPAs).
• Review routine and non-routine QC testing to ensure accuracy and reliability of results.
• Prepare and review technical documentation for regulatory submissions and audits.
• Participate in continuous improvement initiatives to enhance QC processes and laboratory efficiency.
• Represent Quality Control in cross-functional forums, ensuring alignment with organizational goals.
• Collaborate with teams across CMC Development, Manufacturing, Supply Chain, Regulatory, and Quality Assurance.

Skills

Chemistry background

Biology background

Biochemistry background

GMP knowledge

Data analysis

Analytical method implementation

Communication and teamwork

Tools

LabWare LIMS

Excel

PowerPoint

Word

Job description

Proclinical is seeking an Analyst IV for Quality Control Technical Services to support quality and compliance efforts from development through commercialization. This contract-based role based in Boston, MA requires a strong foundation in GMP QC and analytical method transfer.

You will contribute to stability studies, data trending, investigations, CAPAs, and cross-functional collaboration with CMC Development, Manufacturing, Regulatory, and QA.