Hybrid QC Analyst: Method Transfers & Compliance

Integrated Resources, Inc.; Norton (MA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Integrated Resources, Inc. (IRI) in Norton, MA presents a hybrid Quality Control Technical Services (QCTS) Analyst IV role spanning Cambridge and Norton with client contract organizations. The position emphasizes technical specification support, method transfer, stability studies, and QC data trending.

The role requires 8–12 years in GMP QC, strong analytical skills, CAPA experience, and cross-functional collaboration across CMC, Manufacturing, and Regulatory teams.

Qualifications

• 8–12 years in GMP Quality Control function or equivalent industry experience.
• Experience in technical specification development, method transfer, and analytical method implementation.
• Proficient in data analysis and interpretation with attention to detail.
• Solid problem-solving skills and experience in investigations and CAPA.
• Strong organizational and autonomous multitasking abilities.
• Excellent communication and teamwork in a collaborative environment.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Responsibilities

• Provide robust support in the justification of technical specifications for raw materials, intermediates, and finished products.
• Facilitate transfer and implementation of analytical methods from development to routine QC use, including validation and training.
• Assist in execution and documentation of stability studies and shelf-life determinations.
• Engage in collection, analysis, and trending of QC data to monitor quality.
• Support and sometimes lead investigations into quality deviations and CAPAs.
• Review routine and non-routine QC testing for reliability and accuracy.
• Assist in preparing technical documentation for regulatory submissions and audits.
• Participate in continuous improvement initiatives to enhance QC processes.
• Represent QC at cross-functional forums, including CMC meetings, communicating QC needs.

Skills

GMP QC

Data analysis

CAPA investigations

Method transfer

QC documentation

Education

Bachelor's degree in Chemistry or related

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

Integrated Resources, Inc. (IRI) in Norton, MA presents a hybrid Quality Control Technical Services (QCTS) Analyst IV role spanning Cambridge and Norton with client contract organizations. The position emphasizes technical specification support, method transfer, stability studies, and QC data trending.

The role requires 8–12 years in GMP QC, strong analytical skills, CAPA experience, and cross-functional collaboration across CMC, Manufacturing, and Regulatory teams.