Stability Analyst - Quality Assurance (Pharmaceuticals)
CONTRACT PHARMACAL CORP
Hauppauge, NY 11788$70,000 - $90,000 a yearFull Time
Job Description
Description:
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.
Requirements:
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
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.
Requirements:
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