141 applicantsPosted by Agency
SSi People · 22 hours ago
Specialist Product Quality
United States
Full-time
Remote
Mid, Senior Level
5+ years exp
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Responsibilities
Develop and maintain technical GMP documents and oversee product stability studies
Review, verify, report, and archive GMP data for clinical and commercial products
Conduct rigorous data analysis and prepare detailed reports with meticulous attention to accuracy
Execute transactions within GMP computer-based systems such as LIMS and manage associated documentation
Independently manage time-sensitive activities critical to quality assurance processes
Oversee and maintain stability studies within our quality systems, ensuring data integrity and compliance
Lead the documentation and submission of product quality and stability data for regulatory filings
Support site-based GMP inspections and contribute to continuous improvement initiatives
Contribute to SOP development and ensure adherence to regional regulatory requirements
Collaborate closely with cross-functional teams to drive quality and operational excellence
Qualification
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Required
Expertise in stability study design and implementation
Proficiency in data analysis techniques to derive meaningful insights
Strong technical writing skills for documenting procedures and findings
Previous experience in GMP or pharmaceutical settings
Familiarity with MS Office suite (Excel, Word, Project), LIMS, and document management systems
Doctorate degree OR Master’s degree with 3 years of relevant experience OR Bachelor’s degree with 5 years of experience OR Associate’s degree with 10 years of relevant experience OR High school diploma/GED with 12 years of experience
Preferred background in chemistry, biochemistry, biology, or related pharmaceutical sciences
Experience in a regulated environment (GMP) and familiarity with international filing regulations
Preferred
Track record in managing synthetic or biological stability programs
Strong project management capabilities and cross-functional team collaboration experience
Understanding of biologic and synthetic pharmaceutical manufacturing processes
Excellent verbal and written communication skills for effective interaction with stakeholders and regulatory bodies
Company
SSi People
Founded in 1998 and located in Cranberry Twp., PA.
51-200 employees
H1B Sponsorship
SSi People 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
Trends of Total Sponsorships
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Ron Seibert
President and CEO
Company data provided by crunchbase
