Stability Analyst - Quality Assurance (Pharmaceuticals)
hace 3 días
Hauppauge
Job DescriptionDescription: 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, • 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 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, • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field. Master’s degree a plus., • 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