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Senior Associate, Quality Assurance (Billerica) Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system. Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Our experts take a strategic approach to address broader environmental goals from sustainability program development, data-driven decision-making using economics and ecology expertise, data management and validation, software strategy and implementation support, chemistry quality assurance, and EHSS auditing.
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The Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. The Sterile Processing Quality Assurance Specialist embodies the hospital’s core values in all interactions with patients, families, and colleagues.
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Infrastructure Solutions, Emerging Technologies/Digital Transformation, Networking, Storage and Data Protection, Cloud, Virtualization, Systems and DevOps, End User Computing, Data Solutions, Big Data, Database Systems, Business Intelligence and Data Warehousing, Data Science, Application Development, Software Quality Assurance, Agile Transformation, Information Security Solutions, GRC, Enterprise Business Applications, ITSM and Process Improvement, Point-of-Sale (POS) Support.
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Serum extraction and storage- Assists in collecting data for quality assurance and quality control programs- Transfers samples from racks to centrifuges and decant station.
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Reviews all data obtained during all quality assurance activities to ensure consistency with company policies and procedures. Interpret and convey quality assurance philosophy to key personnel in organization.
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External contacts may include departments like Analytical Development, R&D, Quality Assurance, Regulatory, Manufacturing, and Facilities and Engineering. 20-30%: Support QC operations, including data review, data trending, maintenance of equipment and reagents, lab housekeeping, and compliance with quality systems (e.g., SOP revisions.
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Lead clinical data strategy (including external laboratory data) across the C4T portfolio of studies, ensuring the CDM team delivers against time, quality and cost targets. Work closely with cross-functional teams from Clinical Operations, Medical, Biostatistics, Quality Assurance, Pharmacovigilance, and others as needed.
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As new products are introduced, the Senior Associate, Quality Assurance (Warehouse Operation) will support the onboarding of GMP materials through participation in risk assessments, Material Review Board, generation of specifications, master data review and supplier qualification activities.
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The incumbent builds collaborative, supportive relationships and serves as the single point of accountability for Quality Assurance across all clinical development programs including Clinical Operations, Pharmacovigilance, Data Management, Biometrics and other relevant stakeholders.
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Minimum of 6 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry. The ideal candidate for this position should possess several years of experience in the pharmaceutical industry and pharmacovigilance, along with a demonstrated track record of success in managing quality assurance systems and audits.
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The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development.
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The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
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data quality assurance jobs in Lexington, MA
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