Senior Analyst, QA Stability

CONTRACT PHARMACAL CORP • Town of Smithtown, NY

112d • $70,000 - $90,000

About The Position

The QA Stability Sr. Analyst is primarily responsible for being the technical subject matter expert for the stability and retention program which includes drugs, dietary supplements and food products. The Sr. Analyst will develop stability protocols, produce product stability and shelf-life reports in support of product expiry, perform stability assessments, and support the stability and retention sample inventory management aspect of the program.

Requirements

• 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.
• Strong understanding of cGMP, GLP, and ICH guidelines related to stability testing.
• Proficiency in analytical techniques used in stability testing, including, but not limited to, HPLC, GC, and dissolution testing.
• Expertise in data analysis, interpretation of stability data, and experience with statistical software packages (e.g. Minitab).
• Excellent written and verbal communication skills, including the ability to write clear and concise protocols, reports, and regulatory documents.
• Demonstrated analytical and problem-solving skills, with keen attention to detail.
• Ability to work both independently and collaboratively within a team environment.
• Adaptability and flexibility to meet changing project needs and timelines in a dynamic environment.
• Skilled in using Microsoft Office suite.
• Familiarity with Microsoft Access database is a plus.
• Ability to interact, and fluently work in electronic ERP, QMS, LIMS for managing stability data, and similar computer systems.

Responsibilities

• Design, execute, and document stability studies to assess product shelf-life and storage conditions.
• Approve related protocols as applicable.
• Write and/or review related Standard Operating Procedures.
• Approve such SOPs as applicable.
• Write and/or review Deviation Reports related to the stability program.
• Analyze and interpret stability data and documenting results in compliance with regulatory standards.
• Assess the stability impact of changes outlined in Management of Change.
• Calculate product shelf life, prepare shelf-life reports.
• Troubleshoot analytical and product problems, including investigating out-of-specification or unexpected results.
• Provide stability reports to customers and for APR reports.
• Support the management of retain and stability samples in storage areas/chambers.
• Support the monitoring of stability chambers and the stability room and ensure units are operational and within specification.
• Maintain and support any related electronic documentation and sample management systems.
• Collaborate with cross-functional teams, such as quality assurance, manufacturing, regulatory affairs, business development, and account services to ensure product stability and quality, and align with customer expectations.
• Support audits, inspections and requests from health authorities, third parties such as UL, and customers.
• Lead continuous improvement initiatives in all aspects of the stability program.
• Other responsibilities as assigned by management.

Benefits

• Pay Range: $70,000 - $90,000 per year

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees