Opella · 20 hours ago
Quality Associate (FTC)
Virginia
Full-time
Onsite
Mid, Senior Level
5+ years expOpella is a leading company in the Over-The-Counter (OTC) and Vitamins, Minerals & Supplements (VMS) market. The Quality Associate role involves ensuring compliance with quality standards, managing batch release, and overseeing quality metrics while collaborating with various departments to maintain high-quality manufacturing processes.
Health CarePersonal HealthRetail
Responsibilities
Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state
Production processes and areas are audit ready at all times
Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review
Quality behaviours exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP
As Quality Assurance’s representative, be the first point of contact for any issue that may result in change to or deviation from a validated system or process that may impact product quality or safety
Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation
Proactively identify continuous improvement opportunities; potential risks; and cGMP deficiencies to processes and documentation. Work closely with Production and Engineering to implement appropriate improvement or corrective measures
Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times
The management of Product Technical Complaints and associated investigations
Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies
Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality
In conjunction with Area Management ensure that responsible areas are in a state of readiness for regulatory and customer audits with all information readily available
Perform the review/audit of batch records as per approved QA checklist
Be responsible for the position of the Authorised Delegate for the market release of Virginia site manufactured product
Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications
Review and approval of operational GMP documentation as needed
All local Health & Safety requirements
Qualification
Required
University degree in Engineering, Pharmacy or a Science related discipline
Ideally 5 years' experience cGMP regulated environment, ideally with TGA or PIC/s requirements knowledge and exposure (preferably in Pharma or CHC industry)
Technically minded, with an ability to investigate manufacturing issues and root cause analysis
Good knowledge and understanding of GMP, GLP and GDP guidelines and regulations
Strong orientation for quality systems and methodologies to improve production outcomes
Understanding of manufacturing, quality control and quality assurance systems
Strong ability to build and maintain relationships with internal/external stakeholders
Highly organised, active planning and critical thinking skills
Ability to set and action priorities to meet objectives
Highly collaborative and able to influence and achieve results in a team environment
Ability to work independently and as part of a team
Demonstrated Leadership capabilities
A flexible and adaptable approach
A strong dedication to the job combined with a willingness for self-development
Demonstrated good work ethic and attitude
Company
Opella
Opella is a consumer healthcare business segment of Sanofi.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-20Acquired
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