Position Summary

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.

• Job Type: Full-Time
• Location: Hauppauge, NY
• Works Hours: Monday – Friday, 9:00AM – 5:00PM EST
• Pay Range: $70,000 – 90,000 per year, depending on experience
• Start Date: ASAP

What makes this role exciting:

• High-impact, highly visible work – your stability assessments directly support product expiry dating, regulatory submissions, and customer confidence
• True subject matter ownership – you are the go-to expert for stability science, not just executing tasks but shaping best practices
• Exposure to complex pharmaceutical products – work across drug products with varying formulations, packaging configurations, and storage conditions
• Cross-functional influence – collaborate with QA, Manufacturing, Regulatory Affairs, Business Development, and external customers
• Continuous improvement focus – lead initiatives to modernize, optimize, and strengthen stability and retention programs
• Audit- and inspection-facing role – actively support FDA and third-party audits and health authority interactions

Why Join CPC?

At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. 

Responsibilities

In this role, you will:

• 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

Education & Experience

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field. Master’s degree a plus.
• Proven experience (typically 5+ years) in stability studies within the pharmaceutical, OTC, and dietary supplement industries.

Skills, Knowledge & Abilities

• 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