Senior GMP Stability Specialist — Quality Control

SHINE Technologies; North Billerica (MA); On-site; USD 110,000 - 125,000; Full time

Job summary

SHINE Technologies in Massachusetts seeks a GMP Senior Stability Specialist to coordinate, execute, and monitor stability programs, supporting shelf life, regulatory filings, and product quality. The role works cross-functionally with QC, QA, Manufacturing, and Regulatory Affairs to ensure data integrity and timely reporting.

Requirements: Bachelor’s in Chemistry or Pharmaceutical Sciences (Master’s preferred) and 5–8 years in a GMP environment with stability program experience.

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences or related field
• Master’s degree preferred
• 5–8 years of experience in a GMP-regulated pharmaceutical or biotechnology environment
• Experience with stability programs or QC laboratory operations preferred

Responsibilities

• Lead design and lifecycle management of complex stability programs.
• Serve as SME during regulatory inspections, client audits, and internal audits.
• Independently assess stability data and provide shelf-life/retest period recommendations.
• Perform advanced statistical analyses and trend evaluations for quality risks.
• Lead investigations related to stability OOS, OOT, deviations.
• Author and approve stability protocols, reports, and regulatory support documents.

Skills

Stability programs

GMP compliance

Data analysis

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences or related field

Master’s degree preferred

Job description

SHINE Technologies in Massachusetts seeks a GMP Senior Stability Specialist to coordinate, execute, and monitor stability programs, supporting shelf life, regulatory filings, and product quality. The role works cross-functionally with QC, QA, Manufacturing, and Regulatory Affairs to ensure data integrity and timely reporting.

Requirements: Bachelor’s in Chemistry or Pharmaceutical Sciences (Master’s preferred) and 5–8 years in a GMP environment with stability program experience.