Randstad · 4 days ago
Quality Assurance Compliance Specialist
Thousand Oaks, CA
Contract
Onsite
Mid Level
$55/hr - $65/hr
4+ years expRandstad is a top 10 Global Biopharmaceutical employer committed to transforming the pharmaceutical industry through R&D-driven market leadership. They are seeking a Quality Assurance Compliance Specialist to join their Quality Control Validation team, responsible for ensuring compliance with internal procedures and regulatory requirements through the review and approval of validation documents.
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Responsibilities
Reviewing and approving validation documents (e.g., test plans, protocols, reports,) and other related documents to ensure compliance to internal procedures and regulatory requirements
Ensuring that the information contained in the approved validation document(s) is understandable and defendable during inspections
Executing Test Method transfers, investigation, technical writing
Supporting site project validation activities, working as part of the QAV and project teams to review and approve documents in a timely manner, ensuring all cGMP regulatory requirements are met
Qualification
Required
4+ years' experience Quality Control, specifically with Validation Process
Strong interpersonal communication skills with excellent technical writing abilities
Executing Test Method transfers, Test Methods, troubleshooting, investigations
Method verification protocols, SOP and worksheet, Execution of protocols, Methods reports
Experience with Bio burden, Endotoxin, Growth Promotion, Identification, Identity – HPLC, ID-Osmolality, Material Appearance, Osmolality, Solubility, Sterility
Knowledge of the current ISPE Baseline Guidelines for Commissioning and Qualification and GAMP5
Experienced in reviewing and approving Life Cycle Validation Documents including:
Familiar with paperless validation software for life sciences
Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant
Computer System Validation protocols and reports, including SCADA, MES
QC/Micro Laboratory Instrument Qualification and method validation
Company
Randstad
Randstad is the world’s largest talent company and a partner of choice to clients.
10001+ employees
H1B Sponsorship
Randstad 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
2023 (754)
2022 (776)
2021 (1143)
2020 (1749)
Funding
Current Stage
Late StageLeadership Team
Richard Jager
Chief Executive Officer at Randstad Group DACH
Sander van 't Noordende
CEO
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