Galderma · 17 hours ago
Senior Quality Assurance Specialist, Operations
Fort Worth
Full-time
Hybrid
Senior Level
5+ years expGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. They are seeking a Senior Quality Assurance Specialist to provide quality assurance oversight in adherence to current Good Manufacturing Practices (cGMPs) and ensure compliance with Quality System requirements for product distribution and new product introduction.
Pharmaceuticals
Responsibilities
Responsible for the quality release process for finished product distribution, including visual inspection of the finished product for the US market
Manages temperature monitoring program for the distribution center, cold storage area and shipment of finished products
Works with manufacturing sites to resolve quality issues such as consumer complaints, shipping and/or product storage conditions
Review and approve artwork and rework instructions to ensure cGMP requirements are met
Participates in multifunctional project teams to support the introduction of new products and/or changes to current products to ensure compliance with Quality System requirements
Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies
Provides guidance and control directives regarding remediation activities required to continue business operations. Resolves critical issues within the area assigned and may escalate to senior management team based on the severity of the problem
Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of the monthly quality improvement meeting. May be asked to lead process improvement initiatives. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements
Acts as back up for other personnel within QA
Other duties may be assigned
Qualification
Required
Bachelor's degree required
At least five to seven years of related experience in Quality Assurance within a regulated environment or transferrable industry experience
Knowledge of applicable GXP regulations
Knowledge of auditing techniques
Working knowledge of applicable computer software
Good organization and communication skills
Ability to manage multiple tasks
Good writing skills
Benefits
Competitive wage with shift differential
Annual bonus opportunities
Career advancement
Cross-training
Company
Galderma
Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Tom Christenson
Chief Financial Officer
Wendy Johnson
Vice President Strategic Partnerships and Professional Relations
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