cGxPServe

Responsibilities: Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems. Perform a leadership role in statistical programming projects by coordinating study team(s) overseeing timelines assign More...

Responsibilities: Checks claims in advertising and promotional documents against published sources before projects are submitted for medical/regulatory/legal review. Ensures that suitable references are used to support all product and promotional claims in text graphs charts tables a More...

Responsibilities: Has detailed operational knowledge of the equipment to the point that he/she can operate within specified quality/quantity limits. Sets up and debugs equipment to the specifications listed in specifications plant policies and Department Procedures. Deviations from More...

Job Description: Review and approve Qualification protocol. Work with MSAT in the development of protocols based on changes made on the SMPs and MPRs . Assist in investigation and resolving discrepancies and errors during the testing. Review the package of the qualification proto More...

Job Description: The client needs someone with Facilities CQV experience including EMPO Vessel IOV and IOPQ including mixing and temp mapping. They have personnel assigned to Utilities (WFI Alcohol N2 Compressed Air etc. CIP Filter Press Centrifuge CIP skids and Cleaning Validation; t More...

Job Description: Setup operate optimize changeover/troubleshoot and maintain assigned departmental production equipment. Responsible for meeting/exceeding production standards maintaining product quality minimizing/preventing equipment downtime and sustaining budgeted waste levels on More...

Responsibilities: Uses a variety of equipment such as forklifts conveyers cranes handcarts and power trucks to move materials parts assemblies and finished products or goods within a plant office or warehouse. May maintain records. Develops skills in basic tasks techniques and proce More...

Responsibilities: We are seeking a Regulatory Affairs Contractor to contribute to the development and of effective regulatory strategies for investigational products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment. Execute in More...

Job Description: Discovery Biotherapeutics and Genetic Medicine is seeking a highly motivated research scientist to join the Cell and Functional Biology group. In this role you will be responsible for the design and of cell and protein based functional characterization assays for lea More...

Roles & responsibilities: Responsible for overseeing the management and control of qualityrelated documents within an organization. The role involves ensuring compliance with regulatory standards establishing and maintaining efficient document control systems and providing support to More...

responsibilities: Performs any combination of tasks involved in the fabrication manufacture assembly testing and packaging of medical devices as well as setting up operating performing maintenance on and troubleshooting equipment. May conduct quality inspections on processing line i More...

Responsibilities: Validation documentation Authoring (validation plans user requirements specifications risk assessment IQOQPQ protocols trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its r More...

Responsibilities: To support our expansion efforts we are looking to add to our team a person that is experienced in clinical abstraction and large project operations. The role will require wearing many hats and Tempus is looking for an individual that is able to coordinate grow and More...

Responsibilities: Performs any combination of tasks involved in the fabrication manufacture assembly testing and packaging of medical devices as well as setting up operating performing maintenance on and troubleshooting equipment. May conduct quality inspections on processing line i More...

Job description: We seek a multidisciplinary scientist to join clients Discovery Immunooncology to perform proof of concept experiments to advance novel therapeutic modalities. The successful candidate will apply skills in cellular and molecular biology biochemistry immunology and/or More...

Responsibilities: Performs routine production functions including filling utility operations packing packaging assembling labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA (Food and Drug Administration) GMPs (Good Manufactu More...

Responsibilities: Ensures proper patient identification order verification and prepares the patient for the exam. Prepares patients for exam using appropriate body mechanics. Identifies proper exams based on patient need and utilizes correct exam techniques. Produces quality images t More...

Position Overview: The Process Engineer will provide technical support to manufacturing and logistics operations. This includes troubleshooting modifications and improvements related to process systems including cleaninplace steaminplace washing and sterilizing equipment. The engineer More...

Responsibilities: Responsible for the dispensing inspection labeling and packaging of clinical and commercial products. Perform finished product packaging as required to satisfy all customer internal clinical and other demand. Ensure finished product is packaged in accordance with More...

Responsibilities: Client is looking for a versatile individual with deep skills and experience in medical device development to participate in product development product verification and perform compliance activities. Execute testing of electrical mechanical and software components More...