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cGMP
cGMP stands for Current Good Manufacturing Practices (cGMP) and the regulations are set by the Food and Drug Administration (FDA). As you begin your job search is good to familiarize yourself with different industry terms and abbreviations. There seem to be a fair amount to know. 
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Sr Metrology Technician API Job

Novo Nordisk Inc. - Clayton, NC

Diabetes, ERP, Engineer, Engineering, Facilities, Healthcare, Inspector, Instrumentation, Maintenance, Manufacturing, Operations, Pharmaceutical, Quality, SAP, Science, Special Medicine, Technician, Technology

From Novo Nordisk Inc. - 6/25/2018 6:01:47 AM

Project Manager 2 - IT & Automation Job

Novo Nordisk Inc. - Clayton, NC

Compliance, Computer Science, Energy, Engineer, Engineering, Facilities, Law, Legal, Management, Manager, Nuclear, Nuclear Engineering, Operations, Pharmaceutical, Procurement, Project Manager, Science, Technical Writer, Technology

From Novo Nordisk Inc. - 6/25/2018 6:01:47 AM

EHS Specialist

Glenmark Pharmaceuticals Inc., USA - Mahwah, NJ

Key Responsibilities : - Develop safe working techniques, safety policies, guidelines and procedure for Glenmark - Provide daily guidance and direction in EHS programs at the employee/supervisor level to ensure a common and effective approach - Perform incident investigations and assist in corrective action - Conduct warehouse and office job hazard analysis, and recommend preventative/...more

From Glenmark Pharmaceuticals Inc., USA - 6/25/2018 6:01:16 AM

Validation Manager

Glenmark Pharmaceuticals Inc., USA - Monroe, NC

Responsibilities may include but are not be limited to: - Developing a strong documentation package, involving form conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment. - Responsible for timely completion of projects to meet the company objectives. - Responsible for qualification and documentation relate...more

From Glenmark Pharmaceuticals Inc., USA - 6/25/2018 6:01:16 AM

Software Quality Systems Manager - Mobile Medical Device Applications

AstraZeneca Pharmaceuticals - Frederick, MD

Main Duties and Responsibilities Quality professional with strong subject knowledge, both in depth and breadth. Role is responsible for the development, maintenance, and continuous improvement of Software Development Life Cycle programs, systems, and procedures governing connected devices and mobile medical device apps including software that is a medical device. Will also manage, oversee, and/or...more

From AstraZeneca Pharmaceuticals - 6/25/2018 6:00:33 AM

Project Manager

Catalent Pharma Solutions - San Diego, CA

The Role (daily responsibilities) •Work directly with Client-side Project Managers to develop, write and process work orders as part of the RFP process. Liaise between clients, science and manufacturing teams to drive project and process solutions. •Prepare and present monthly/quarterly (or as required) project updates to client management via telephone and at client sites. •Manage all clien...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Pharmaceutical Process Engineer I

Catalent Pharma Solutions - San Diego, CA

The Role (daily responsibilities) •Set up and operation of small scale and pilot scale pharmaceutical manufacturing equipment •Evaluation of drug product formulation processes and procedures •Execution of demonstration batches prior to cGMP productions •Participation in planning and execution of cGMP productions •Exercise technical discretion and critical thinking in the design, execution ...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Manufacturing Production Technician I - III

Catalent Pharma Solutions - San Diego, CA

The Role (daily responsibilities) • Responsible for manufacturing of cGMP products, following SOPs, and providing accurate documentation in production batch records.  • Provides guidance and training for junior operators. • Operates automated or semi-automated equipment. • Prepares materials and equipment for production. • Supports equipment cleaning verification and validation activit...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Quality Assurance Associate

Catalent Pharma Solutions - Windsor, Ontario

The Role •Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and Quality Assurance (QA) management as required •Performs in-process review of documentation and ensures all product has been manufactured in compliance with cGMPs (Good manufacturing Practices) and SOPs (Standard Operating Procedures).  This includes c...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Quality Assurance Associate

Catalent Pharma Solutions - Strathroy, Ontario

The Role •Performs in-process document auditing and product quality checks in production and ensures all issues are communicated to production employees, production management and Quality Assurance (QA) management •Performs Final Release auditing of batch documentation ensure all product has been manufactured in compliance with cGMP's (Good Manufacturing Practices) and SOP's (Standard Oper...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Scientist, AR&D

Catalent Pharma Solutions - St. Petersburg, FL

The Role •Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols. •Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data •Writes and reviews anal...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

QA Inspector (Production) 2nd shift role

Catalent Pharma Solutions - Philadelphia, PA

The role of the Quality Inspector (Production 2nd shift) is critical to the end user which are our patients.  It directly affects patients risk and safety if inspections are not done properly according to cGMPs, DEA and OSHA rules and regulations.  Quality, safety, and on-time delivery is a must to be successful in this role! The Role •Responsible for ensuring that Standard Operating Procedures ...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Senior Associate Scientist, Biologics

Catalent Pharma Solutions - Kansas City, MO

The Role (daily responsibilities) •In support of large molecule therapeutics, under direction, may perform method validation or transfer activities. •Perform activities under cGMP as appropriate. •May draft technical documents such as methods or certificates of analysis. •Performs parallel review of laboratory documentation and may become qualified to perform technical review of documents fo...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Associate, Production Testing - C Shift

Catalent Pharma Solutions - Woodstock, IL

The Role • Standardization and use of simple analytical instrumentation (pH meter, osmometer, torque meter, balance) and measurement devices (ruler, micrometer, go/no go gauges) • Material/Product sampling per a pre-defined schedule • Evaluation of materials/products for conformance to visual and functional specifications • Complete, accurate, detailed and legible documentation of sampli...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Material Handler - D Shift

Catalent Pharma Solutions - Woodstock, IL

The Role (daily responsibilities) •Follow safety and manual handling guidelines. • Read, comply, and perform required documentation on all Manufacturing Work Orders and Standard Operating Procedures. • Supply the packaging lines with the material required by the Parts List. • Remove excess packaging materials and transfer to appropriate areas. • Perform pick-up, transfer, and shrink wrap...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Distribution, Receiving and GMP Storage Team Lead - 2nd Shift

Catalent Pharma Solutions - Kansas City, MO

The Role/Daily Duties: • Safety, Quality, Delivery, Cost and People - Lead and support daily stand-up meetings to review and improve Safety, Quality, Delivery, and Cost  • Responsible for the reaction, investigation, and improvement of Safety Events (as assigned) for Shift operation.  • Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks in Distribution, Re...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Manager of Pre-Production & Label Control

Catalent Pharma Solutions - Kansas City, MO

The role of Manager of Pre-Production & Label Control leads the activities of the Preproduction and Label Control groups. The Preproduction groups function is to prepare the Production operation to execute Label Printing and Primary and Secondary Packaging. The Label Control groups function is to facilitate the design of outsourced labels and to design and print in-house labels for use in Packagin...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Distribution Associate II - 2nd Shift

Catalent Pharma Solutions - Kansas City, MO

The Role/Daily Duties: •Fill and/or process orders for shipment •Perform monthly inventory checks to ensure accurate inventory levels and correct placement of inventory •Restock shipping/warehouse supplies •Ability to work in a fast pace, high-stress environment •Verify and Label orders at pack out; Restock shipping/warehouse supplied The Candidate/ Qualifications Education or Equivalen...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Quality Control Team Lead

Catalent Pharma Solutions - Kansas City, MO

The role of the Quality Control Team Lead will be to provide and report materials management data as required by project contracts within the Quality Department at the Kansas City, MO site. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects. The Quality Control Team Lead will repor...more

From Catalent Pharma Solutions - 6/25/2018 6:00:00 AM

Senior Specialist Quality Assurance, Biological Critical Reagents

Merck & Co. - North Wales, PA

Education Minimum Requirement: • B.S. and/or M.S. in Biology, Molecular Biology, Biochemistry, or related biological science Required Experience and Skills: • Bachelor's with 4+ years of quality experience; Master's with 2+ years of quality experience • Ability to work independently • Strong quality mind and technical knowledge • GMP experience Preferred Experience and Skills: •...more

From Merck & Co. - 6/25/2018 5:59:38 AM
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