cGxPServe

Job Description: The position of Warehouse Team Member performs activities related to the receipt shipment movement manufacture or control of raw materials product recyclable materials and waste. Operates equipment/machinery when necessary. Responsibilities: Performs activities relat المزيد...

Responsibilities: Support the plant manufacturing effort with ability to identify problems and specific focus will be in areas of improving quality waste and equipment efficiencies. Application of Transfer functions during troubleshooting and production support (i.e. Statistical Tole المزيد...

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures. Develops protocols and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validat المزيد...

Job Description: We are seeking an experienced Manufacturing Engineer to support a comprehensive documentation gap assessment and remediation effort within our medical device manufacturing operations. This individual will play a critical role in evaluating and updating manufacturing المزيد...

Job Description: Seeking a Scientist with experience in regulated bioanalytical laboratories (GLP) to perform quantitative analysis of biological samples using HPLC-MS. The role involves sample extraction instrument operation data processing and documentation in compliance with GLP an المزيد...

Note: Hours could be 20-40. Need to have night and weekend availability (primarily weekend) or doubles on the weekend 0645-2315. For orientation must have the ability to dedicate approximately 6 weeks on all 3 shifts for training. Job Description: Participate in the execution of prot المزيد...

Responsibilities: Execute Design Verification/Validation Strategies with emphasis on. Technical analysis of requirements specifications and control strategy. Alignment of design outputs to production and process controls. Proper verification techniques including inspection demonstrat المزيد...

Roles & Responsibilities: Minimum 3 years experience with SAP or Blue Yonder Warehouse Management Systems. 3 years experience with System Development Lifecycle. 3 years experience in Computer System Validation. Experience with FDA CSA principles Experience with J&J CSV Framework Expe المزيد...

Job Description: We are seeking a Principal Process Engineer with a strong background in GMP manufacturing and engineering. The ideal candidate will have hands-on experience in biologics process systems automation and utilities with a focus on upstream and/or downstream processes. Th المزيد...

Responsibilities: Responsible for preparation of the Quality sections of INDs/IMPDs new marketing authorization applications post-approval variations renewals and responses to agency questions for a range of biologics products. Extensive interaction with departments outside of CMC Re المزيد...

Responsibilities: Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings. Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected reviewed and delivered المزيد...

Job Description: In this role you will be responsible for planning organizing and leading projects to support the development of new packaging systems and or components that enhance and preserve high value products. The ideal candidate will drive technical projects work with cross-fu المزيد...

Roles & Responsibilities: Bs degree in mechanical with years experience and Handson experience in SolidWorks for designs. Experience in design drafting CAD modelling GD&T. Completes structural calculations on development of design modifications / designs and advise on analyses modifi المزيد...

Responsibilities: Carry out all aspects of a validation project which includes authoring and executing Validation Master Plan (VMP) Validation Plan (VP) Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols/report in accordance wi المزيد...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi المزيد...

Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for exist المزيد...

Job Description: The Operations Specialist I is a multi-functional role responsible for inventory control of materials and finished goods formulation packaging and order fulfilment. The Operation Specialist I also supports Quality Control of finished goods by performing dye labelling المزيد...

Job Description: Collaborate with a cross-functional design team to develop Client cardiovascular device/therapy providing quality leadership and vision throughout the initial product development cycle up to commercialization while ensuring compliance with applicable internal and ext المزيد...

Job Description: Were looking for an individual with experience in validations particularly with USP Water chiller (utilities) and C&S. Roles & Responsibilities: Bachelors degree. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. المزيد...

Responsibilities: Follow all company safety rules regulations and job safety analyss. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited. Discarding obviou المزيد...