QC Technical Services Lead: Method Transfers CAPA

Planet Pharma; Norton (MA); Hybrid; USD 76,000 - 90,000; Full time

Job summary

Planet Pharma in Norton, MA, offers a hybrid Quality Control Technical Services Analyst IV role spanning Cambridge and Norton locations. The position supports stability studies, data trending, investigations, method transfers, and technical specification support to ensure GMP quality across development to commercialization.

The successful candidate holds a BS in a scientific field, 8–12 years in GMP QC, and proven experience with data analysis, CAPA, and collaborative cross-functional work.

Qualifications

• BS in chemistry, biology, or biochemistry; advanced degrees considered.
• 8–12 years in GMP QC or equivalent in pharmaceutical/biotech.
• Experience in technical specification development and method transfer.
• Data analysis with strong attention to detail.
• Excellent communication and teamwork skills.

Responsibilities

• Provide robust support in justification of technical specifications for raw materials, intermediates, and finished products.
• Facilitate transfer and implementation of analytical methods from development to routine use within the QC lab, including method 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 identify quality issues and ensure continuous product quality.
• Support and lead investigations into analytical and product-related deviations, implementing CAPAs.
• Review routine and non-routine QC testing for accuracy and regulatory compliance.
• Prepare and review technical documentation for regulatory submissions and audits.
• Participate in continuous improvement initiatives to enhance QC processes and efficiency.
• Represent QC in cross-functional forums, including CMC meetings.

Skills

Data analysis

Attention to detail

Communication

Teamwork

Autonomy

CAPA

Education

B.S. in Chemistry/Biochemistry

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

Planet Pharma in Norton, MA, offers a hybrid Quality Control Technical Services Analyst IV role spanning Cambridge and Norton locations. The position supports stability studies, data trending, investigations, method transfers, and technical specification support to ensure GMP quality across development to commercialization.

The successful candidate holds a BS in a scientific field, 8–12 years in GMP QC, and proven experience with data analysis, CAPA, and collaborative cross-functional work.