Roles & Responsibilities. Develop QMS and overall Product Quality Methodology (i.e. product development process, tools/process such as FMEA, dFx, NPI, manufacturing, quality assurance). Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms/templates, etc.). ISO 9001 Ready/Capable by roughly end of 2024. Support existing team members with training, reviewing existing processes, documents, capabilities, identi...
Roles & Responsibilities. Develop, execute, and review comprehensive validation protocols for autoclaves and sterilizers, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Conduct thorough risk assessments to identify potential equipment and process-related risks and implement effective mitigation strategies. Collaborate with cross-functional teams, including engineering, production, an...
Spark Life Solutions. is seeking a skilled. Business Analyst. with experience in. GxP Suppliers and SAP. (specifically QIR and purchasing controls, including block/unblock functionalities) to support our client. Location. Foster City, CA. Roles & Responsibilities. Ensure all requirements are captured accurately to guide project development effectively. Use case preparation to design and test systems, ensuring accuracy. Coordinate with stakeholder...
Spark Life Solutions. Seeking a. Jr. Project Manager. to support our clients with the planning, execution, and delivery of projects within the organization. Location. Redwood City, CA. Primary Responsibilities. Assist in the development of project plans, including scope, timelines, and resource allocation. Monitor project progress and provide regular updates to senior management and stakeholders. Coordinate with cross-functional teams to ensure p...
Roles & Responsibilities. Process Engineer should possess at a minimum five (5) years of experience in pharmaceutical support, process engineering and process validation. Knowledge of EMEA (Annex 1) and FDA (21CFR200s, 210s, 600s). Complete engineering feasibility study to determine if sonication capabilities can be added upstream of vial washer. Perform engineering study on vial washer using riboflavin and potentially microsphere suspensions and...
Job Description. Responsible for quality oversight of the design, development, and production of medical device and combination products with focus on risk mitigation, phase appropriate design reviews, continuous improvement, and qualification strategy implementation. Job Title: Quality Engineer. Location: Texas. Roles & Responsibilities. Represent the quality function in product development projects providing support for development and commerci...
Job Title : Quality Engineer. Location: Waltham, MA. Maintain and improve the Quality System to ensure compliance with ISO standards, QSR Regulations, and MDSAP. Provide front and backroom support during external regulatory body audits and factory inspections such as FDA, TUV, Partners, and Customers. Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements. Dri...
