Responsibilities: Develop and execute commissioning, qualification, and validation protocols for equipment, utilities, and facilities in line with industry regulations and client specifications. Assist in the creation and revision of St...
Responsibilities: Perform technical tasks related to product functional assessment including, but not limited to, concept feasibility, design verification, sustaining engineering, and new product development of medical devices. Execution...
Responsibilities: As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, d...
Responsibilities and Requirements : The client has deliverables coming up and needs a consultant to help hit specific deadlines. This role is a combo device position, the consultant is required to have experience with prefilled syringes,...
Responsibilities: The client has deliverables coming up and needs a consultant to help hit specific deadlines. This role is a combo device position, the consultant is required to have experience with prefilled syringes, Class II/III devi...
Responsibilities: Provides regulatory leadership to assigned platform teams providing regulatory guidance throughout the product development lifecycle and coordinating team inputs for regulatory submissions. Works with Associate Director...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, en...
Responsibilities: Minimum of 4 years of experience in laboratory management or laboratory informatics, with a strong understanding of LIMS systems and their applications. Strong analytical and problem-solving skills, with the ability to ...
Top 3 skills: Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufactu...
Responsibilities: Supports all activities for the Quality Assurance Label Control group. Responsible for issuing clinical and commercial in-process and final product labels for labelling operations. Responsible for ensuring accurate pri...
Responsibilities: Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission). Act as the point of contact with regulatory agencies. Provide guidance on local mechanisms to optimize product...
Responsibilities: Perform technical tasks related to product functional assessment including, but not limited to, concept feasibility, design verification, sustaining engineering, and new product development of medical devices. Execution...
Responsibilities: Strong programming skills in SAS / R programming and data analysis. Extensive work experience with large US insurance claims databases, electronic medical records, registry databases for health outcomes research (e.g., ...
Responsibilities: Provide programming support for study deliverables as assigned, ensuring that timelines are met and expected quality is attained. Liaise with Data Management and Biostatistics for database and dataset specifications, ti...
Responsibilities: Provide first line monitoring support for SAP application modules, covering GMT time zone. Investigate issues with iDocs and other data transport objects throughout the GMT time zone and report and track issues to exter...
Responsibilities: Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas. Validation protocol writing, review, and execution (or over seeing validation execution). SOP review, creation, and approval. OOS i...
Responsibilities Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify. Produce GxP documentations for the instrument software validation. Own change controls and deviation management Prepare and execute IQ/OQ...
Responsibilities: Act as SME for team members in resolving any technical and operational issues. Good understanding of the domain and related processes. Independently interact with client and handle/address any queries from client. Pro...
Responsibilities: Work collaboratively with process, engineering, and production teams to assess requirements and influence the design of automation systems. Play a key role in the development and implementation of innovative automation ...
Responsibilities: To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the standards required for regulatory submissions for all INDs and NDAs/MAAs. Responsible for Statistical Programming...