Solvias · 23 hours ago
Qualification Validation Specialist
Morrisville, NC
Full-time
Onsite
Entry, Mid Level
2+ years expSolvias is a global provider of chemistry, manufacturing, and control analytics to the life sciences industry. The Qualification Validation Specialist serves as a Subject Matter Expert for the Qualification Validation Management function within the Quality Assurance department, focusing on equipment qualification and compliance oversight in a GMP laboratory environment.
CosmeticsManufacturingMedical DevicePharmaceutical
No H1B
Hiring Manager
Daejia C. Hood, MBA, NCCP, SPHR, SHRM-SCP
Responsibilities
Assists with the establishment of proper equipment maintenance and performance tracking throughout equipment life cycle
Method validation/transfer/verification activities and documentation per corresponding internal and regulatory requirements
Serve as an SME for equipment qualification within Quality Assurance, as well as for proper equipment qualification life cycle management and compliance oversight for shared systems (e.g., LIMS, Empower, etc.)
Advises and assists with preparation and review of equipment service agreements, user requirement specifications (URS), installation/operational/performance qualification (IQ/OQ/PQ) documentation, risk assessments and other qualification documents
Perform and assist with compliance activities relating to method validation, transfer, and verification
Assist with compiling and tracking qualification and validation item status, associated metrics, and quality management system processes (e.g., process change control, quality events/deviation, CAPA, audit observations, etc.)
Support continuous improvement in QVM and associated processes
Qualification
Required
Bachelor's degree in a technical, scientific, or other relevant discipline
Minimum of 2 years of experience in a qualification and validation role in a pharmaceutical/biotechnology environment
Familiarity with various types of laboratory equipment (cell-based bioassay, physical chemistry, molecular biology, virology)
Working knowledge of US and EU GMP regulations for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems
Familiarity with biologics and/or pharmaceutical Quality Management Systems and regulations
Knowledge of Data Integrity rules and requirements
Experience in writing validation protocols and reports
Preferred
Experience in a CRO/CDMO is strongly preferred
Experience in a site start-up is strongly preferred
Familiarity with Quality and laboratory systems such as Labware LIMS, MasterControl, Empower, Chromeleon
Willingness to learn and carry out new and complex tasks
Ability to work both independently and collaboratively with internal and external stakeholders
Knowledge of word processing, spreadsheet, and database applications
Excellent analytical and problem-solving skills
Strong attention to detail and organizational abilities
Effective communication and interpersonal skills
Company
Solvias
Solvias provides contract research, development, and manufacturing for the pharmaceuticals, biotech, medical devices and cosmetics industry
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Archie Cullen
Chief Executive Officer
Jarlath Keating
President
Recent News
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