Contract Pharmacal Corp · 3 months ago
Senior Analyst, QA Stability (Pharmaceuticals)
Hauppauge,NY,US
Full-time
Onsite
Mid, Senior Level
$70K/yr - $90K/yr
5+ years expContract Pharmacal Corp is a company in the pharmaceuticals sector, seeking a Senior Analyst for their QA Stability team. The role involves being the technical subject matter expert for the stability and retention program, developing stability protocols, and collaborating with cross-functional teams to ensure product stability and quality.
BiotechnologyPharmaceutical
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
Qualification
Required
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 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
Ability to interact, and fluently work in electronic ERP, QMS, LIMS for managing stability data, and similar computer systems
Preferred
Master's degree a plus
Familiarity with Microsoft Access database is a plus
Company
Contract Pharmacal Corp
Contract Pharmacal Corp is a pharmaceuticals company specializing in solid dose drugs and dietary supplements.
1001-5000 employees
H1B Sponsorship
Contract Pharmacal Corp has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (6)
2022 (5)
2021 (7)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Larry Lapila
Vice President of Business Development
Glenn Langberg
Chief Strategy Officer (CSO)
Recent News
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