Stability Analyst - Quality Assurance (Pharmaceuticals)

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

15h•$70,000 - $90,000•Onsite

About The Position

We’re looking for an experienced Stability Analyst to take ownership of pharmaceutical stability programs that directly impact product quality, shelf life, and regulatory success. This is not a routine QA role. You’ll serve as the technical stability expert, partnering across Quality, Manufacturing, Regulatory, and customers to ensure products meet the highest scientific and regulatory standards – throughout their entire lifecycle.

Requirements

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field.
Proven experience (typically 5+ years) in stability studies within the pharmaceutical, OTC, and dietary supplement industries.
Strong knowledge of cGMP, GLP, and ICH stability guidelines (Q1 series)
Experience with pharmaceutical dosage forms and packaging systems
Proficiency with stability-related analytical techniques (e.g., HPLC, GC, dissolution)
Ability to analyze and trend stability data; experience with statistical tools such as Minitab
Excellent technical writing skills (protocols, reports, regulatory documentation)
Strong analytical, troubleshooting, and problem-solving abilities
Comfortable working independently while collaborating across functions
Experience working in ERP, QMS, and LIMS environments
Proficient with Microsoft Office; Microsoft Access experience is a plus

Nice To Haves

Master’s degree a plus.
Microsoft Access experience is a plus

Responsibilities

Design, execute, and document pharmaceutical stability studies to support shelf life, storage conditions, and packaging performance
Serve as the technical subject matter expert for the stability and retention program
Author, review, and approve stability protocols, reports, SOPs, and related documentation
Analyze and trend stability data; interpret results to support expiry dating and regulatory expectations
Calculate product shelf life and prepare detailed stability and shelf-life reports
Assess stability impacts related to change control / management of change
Investigate and resolve stability-related deviations, OOS, and atypical results
Provide stability data and reports for customers and Annual Product Reviews (APR)
Support the management and tracking of retain and stability samples
Ensure stability chambers and storage areas operate within qualified conditions
Maintain stability data within electronic systems (ERP, QMS, LIMS)
Support FDA inspections, customer audits, and third-party assessments
Drive continuous improvement initiatives within the stability program