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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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Production Supervisor II

CSL Behring - Kankakee, IL

Main Responsibilities and Accountabilities: 1. Achieve production goals for Safety, Quality, and Capacity 2. Ensure compliance to cGMPs in manufacturing 3. Establish adequate coverage  of facility, personnel, and equipment resources to support the manufacturing schedule. •Coordination of daily job assignments. Identify overtime requirements. •Coordination of PM's, Calibrations, Qualifications...more

From CSL Behring - 2/19/2018 6:37:30 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 - 2/19/2018 6:37:19 AM

Analytical Chemist

Catalent Pharma Solutions - Malvern, PA

The Role •Carry out all duties in line with MTI quality procedures, cGMP regulatory guidelines and MTI safety standards. •Perform analytical testing of pharmaceutical materials in accordance with client test methods, MTI test methods, compendial (e.g. USP, EP etc.) methods etc. •Verify cleaning of processing equipment through analytical testing procedures. •Technical training of analytical ...more

From Catalent Pharma Solutions - 2/19/2018 6:37:19 AM

Manufacturing 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 - 2/19/2018 6:37:19 AM

Production Associate II - D Shift

Catalent Pharma Solutions - Woodstock, IL

The Role •Monitor and direct employee position rotations on the line. •Assist team lead in the coordination of OJT. •Make certain material inventory is accurate. •Perform routine maintenance, set-ups, changeovers, and troubleshooting of packaging equipment as necessary. •Count rejects. •Inform technician(s) of any machine problems. •Maintain effectiveness of the Quality System components...more

From Catalent Pharma Solutions - 2/19/2018 6:37:19 AM

Associate GMP Cleaning Technician, 2nd Shift

Catalent Pharma Solutions - Kansas City, MO

Responsibilities: • R esponsible for adhering to policies and procedures with an emphasis on regulatory related processes such as SOPs, cGMP and safety in compliance with the CFRs and meets the business needs of the organization. Ensure that the facility is kept tour ready at all times and people/material/flow/cleaning and zone concepts are maintained at all times • Ensures equipment and roo...more

From Catalent Pharma Solutions - 2/19/2018 6:37:19 AM

Packaging Senior Supervisor/Packaging Manager (Second Shift)

Sun Pharma - Cranbury, NJ

Bachelor Degree or College Diploma in related field, preferably in pharmaceutical sciences Minimum 4 years of pharmaceutical packaging supervision or packaging management experience is required Must have bottling experience within a pharmaceutical manufacturing environment Strong background in line operations and line balance Strong knowledge of cGMPs, SOPs, FDA guidelines, and saf...more

From Sun Pharma - 2/19/2018 6:36:45 AM

Associate Director, Data Integrity Site Lead

Merck & Co. - Elkton, VA

Minimum Requirements: • BS degree required, with concentrations in Science, Engineering, or IT. •Minimum 7 years applied professional work experience in one of the following pharmaceutical work areas: quality operations, compliance, manufacturing operations, technical operations, IT in a cGMP industry. •Working knowledge of computerized systems/ IT required, including SDLC. •Strong worki...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Associate Director, Quality Systems

Merck & Co. - Durham-RTP, NC

Minimum Requirements: • BS or BA degree in Engineering or Science •Minimum of Eight (8) years experience in the Pharmaceutical industry with significant experience in biologics, vaccines and/or biopharmaceuticals compliance •Minimum Five (5) years of leading/managing experience •Understanding of FDA regulations and cGMPs with experience in deviation management, CAPAs, complaints, complia...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Associate Specialist

Merck & Co. - West Point, PA

Education: • Bachelor's Degree or higher in Science or Engineering discipline Required: • Willing and able to work alternate shifts and weekends during start-up and demonstration to meet critical business needs • Good verbal and written communication skills • Ability to effectively respond to change • Excellent analytical and organizational skills • High personal integrity, cred...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Drug Substance Downstream Process Support Lab Senior Specialist

Merck & Co. - West Point, PA

Education Minimum Requirement: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with five (5) years of relevant GMP experience - OR - a Master of Science Degree with three (3) years of relevant GMP experience - OR - a Ph.D. with relevant academic experience . Required Experience and Skills: • Experience in vaccine or biologics manufa...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Drug Substance Process Support Lab Specialist

Merck & Co. - West Point, PA

Education Minimum Requirement: • Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with a minimum of two (2) years of relevant GMP experience. Required Experience and Skills: • Experience in vaccine or biologics drug substance manufacturing within an aseptic, cGMP environment • Experience authoring technical documentation within a...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Drug Substance Upstream Process Support Lab Senior Specialist

Merck & Co. - West Point, PA

Education Minimum Requirement: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with five (5) years of relevant GMP experience - OR - a Master of Science Degree with three (3) years of relevant GMP experience - OR - a Ph.D. with relevant academic experience . Required Experience and Skills: • Experience in vaccine or biologics manufa...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Senior Specialist, Quality Assurance

Merck & Co. - West Point, PA

Education: • B.S., M.S. and/or PhD. degree in an appropriate Science, IT, Computer Science or Engineering discipline. Required: • Minimum of 5 years' experience with B.S./M.S., OR five (5) years with PhD. • Experience should be in pharmaceutical/biotechnology, Computer, IT industry with five (5) years in an IT, Computer, quality or compliance role. • Extensive working knowledge of cGMPs ...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Quality Control Analyst II

Teva Pharmaceuticals USA - Cincinnati, OH

Qualifications EDUCATION & EXPERIENCE BS or higher in science related discipline Minimum 2 years of experience in a pharmaceutical environment Connect With Us! Not ready to apply? Connect with us for general consideration. Do YOU have great ideas? Want to work in an environment that will nurture your professional development? Come and join Teva on its journey of growth. Teva...more

From Teva Pharmaceuticals USA - 2/16/2018 5:51:10 AM

Critical Systems Operator

Teva Pharmaceuticals USA - Irvine, CA

Qualifications Education Required: High School diploma or equivalent. Education Preferred Completion of vocational courses in areas such as welding, mechanics, control systems, electrical, refrigeration, HVAC, or Freeze drying is desirable. Refrigeration license or technical school certificate is highly desirable. Experience Required: Experienced in repair, installation or maintenance to H...more

From Teva Pharmaceuticals USA - 2/16/2018 5:51:10 AM

Group Leader Quality Control

Teva Pharmaceuticals USA - Cincinnati, OH

Qualifications Education: •Bachelor's of Science Degree in Chemistry or related quantitative scientific discipline required Experience: •Minimum 5 years of progressive pharmaceutical QC laboratory experience required Technical Skills: •Excellent knowledge of cGMPs and their application to a pharmaceutical QC laboratory; thorough knowledge of compendia USP, EP and ICH guidel...more

From Teva Pharmaceuticals USA - 2/16/2018 5:51:10 AM

Specialist, cGMP Biomanufacturing - 2nd Shift Wednesday through Saturday

Catalent Pharma Solutions - Madison, WI

Responsibilities: • Performs daily review of executed cGMP documentation (BPRs, forms). Executes and properly documents cGMP Biomanufacturing activities. • Operates and troubleshoots cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and      Biosafety Cabinets (BSC) or Laminar Flow H...more

From Catalent Pharma Solutions - 2/16/2018 5:50:47 AM

cGMP Biomanufacturing Manager

Catalent Pharma Solutions - Madison, WI

The Role •The cGMP Biomanufacturing group is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish. This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufacturing operati...more

From Catalent Pharma Solutions - 2/16/2018 5:50:47 AM

Product Development Manager

Catalent Pharma Solutions - Swindon, Wiltshire

Job Description Catalent offers rewarding opportunities to further your career " join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by...more

From Catalent Pharma Solutions - 2/16/2018 5:50:46 AM
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