Analyst IV, Quality Control Technical Services

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

Analyst IV, Quality Control Technical Services - Contract - Boston, MA

Join a cutting-edge pharmaceutical team where your precision and passion for quality analysis will help shape the future of life-saving medicines!

Proclinical is seeking an Analyst IV for Quality Control Technical Services to support quality and compliance efforts from development through commercialization.

Primary Responsibilities:

This role involves contributing to stability studies, data trending, investigations, and facilitating method transfers. The position plays a key part in ensuring the efficiency and effectiveness of QC functions while maintaining regulatory compliance.

Skills & Requirements:

• Background in chemistry, biology, biochemistry, or a related scientific field.
• Experience in a GMP Quality Control function within the pharmaceutical or biotech industry.
• Proficiency in technical specification development, method transfer, and/or analytical method implementation.
• Strong data analysis skills with attention to detail.
• Problem-solving expertise, including conducting investigations and implementing CAPAs.
• Excellent organizational skills and ability to manage multiple tasks independently.
• Effective communication and teamwork abilities in a collaborative environment.
• Familiarity with LabWare LIMS, Excel, Word, and PowerPoint is preferred.

The Analyst's responsibilities will be:

• 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.

Compensation:

• $55 to $68 per hour.