Job Description: The GMP QA Analytical Sr. Quality Specialist recognized as a subject matter expert in the principles.... Key Duties and Responsibilities: Provides QA review of the GMP data in support of stability and release of clinical...
Job Title: Engineer, GMP Drug Delivery Medical Device (JP13653C) Location: Cambridge, MA 02138 OR Thousand Oaks, Ca... and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development...
Job Description: The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification... cycle of the project. This position reports directly to the Manager of Validation. Key Responsibilities: The...
) Validation Summary Reports for WFI upgrade. Requirements: Must be willing to work onsite in Boston, MA Bachelor's Degree... skills Strong attention to detail GMP and Good Documentation Practice Intermediate skills with WORD (authoring/editing large...
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... such as method validation/verification and method transfer Be accountable for the success of ALCM projects/activities and ensure...
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... requirements of the role. Knowledge, Skills and Abilities: Microbiology background is a plus GMP exp is a plus Performed...
correctness of laboratory notebooks, worksheets, logbooks, and electronic records, ensuring compliance with GMP standards. Method... Validation: Review complex documentation related to analytical method validation, verification, and transfer. Audit Trail Review...
analysis, and laboratory operations within a GMP environment: Primary Responsibilities: Work with client team on routine... testing and if needed for method transfer or qualification Make and Review entries in DELTAV, CMMS, validation software, LIMS...
all activities under Good Manufacturing Practices (GMP) guidelines. The Quality Control Specialist is responsible for supporting... a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting...
method validation, verification and transfer testing and ensure that the testing is conducted as per approved protocols... in a GMP Quality Control function or equivalent, relevant industry experience with demonstrated increase in responsibility...
analysis, and laboratory operations within a GMP environment: Primary Responsibilities: Work with client team on routine... testing and if needed for method transfer or qualification Make and Review entries in DELTAV, CMMS, validation software, LIMS...
of group members Author and submit revisions to controlled documents in VeeQMS in support of GMP Operations. Knowledge..., and facility validation experience Proficiency with business tools such sample management systems, MES and similar tools used...
development, qualification, and validation as well as GMP activities (release and stability) are executed. The role of Scientist...
carries out all activities under Good Manufacturing Practices (GMP) guidelines. The Quality Control Specialist... validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur...
, culture optimization, cell counting, cryopreservation, and validation methods. Experience in experimental design, data.... Manufacturing, or experience in pharmaceuticals/biologics processing in a GMP 1-2 years experience in a manufacturing environment...
, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed... standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance. Actively participate...
product release, complaint management, data management, calibration and validation requirements, conducting investigations..., management of Quality systems for deviations, change controls and CAPAs, validation and maintenance of equipment, quality support...
, and validation of analytical methods: Primary Responsibilities: Optimize, technical transfer, qualification, and validation... of complex GMP release and stability assays including cell-based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS...
, and validation of analytical methods: Primary Responsibilities: Optimize, technical transfer, qualification, and validation... of complex GMP release and stability assays including cell-based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS...
ACDM, DPT, AS, Quality, Regulatory and clinical supply) Extensive knowledge of GLP and GMP activities Understands the... technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation...
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