Lugoff, SC, 29078
... 1995-1997 Clinical Development Pfizer Inc., Groton, CT Organized and assembled applications for new medications to be submitted to FDA for approval. Team member for checks and balances system instituted for verification of completeness and ...
- Apr 10
Dayton, NJ
... Experienced in tablet manufacturing processes including blending, granulaƟon, compression, and coaƟng, along with strict adherence to cGMP, SOPs, and FDA regulaƟons. Proven ability to maintain accurate documentaƟon, support audits, and collaborate ...
- Apr 10
Cincinnati, OH
... Worked closely with product development to develop a new skull clamp and get it through the FDA approval with strict ISO13485 standards. 1/3 of the time, I was scheduling production and leading production meetings. Was on team setting up for our new ...
- Apr 10
Woodstock, IL
... Completed and reviewed cGMP Documentation of laboratory results using Empower software in ELN per FDA regulations. Trained new associates on methods and procedures. Documentation of instrument calibration in Blue Mountain software. Decommissioning ...
- Apr 10
Waltham, MA
... • Contributed to Pre-IND (Type D) FDA meeting preparation and filing data packages: bridged scientific and regulatory strategy in a context with direct asset-value implications. • Led cross-functional advisory role for novel DNA/mRNA LNP drug ...
- Apr 10
Springfield, MO
... Customer inquiry handling Performance management Order fulfillment Organizational skills Packaging Unloading trucks Loading FDA regulations Outbound logistics Retail sales transactions Distribution management Microsoft Word Warehouse management ...
- Apr 10
Houston, TX
... Nurse Practitioner • Evaluate, diagnose, using evidence-based tools, treat and manage medications with FDA-approved guidelines for conditions such as Depression, Anxiety, ADHD, OCD, PTSD, and other mental illnesses in adults and Children. ...
- Apr 09
Raleigh, NC
... • Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research. • Responsible to maintain personal currency documentation per TFS SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM ...
- Apr 09
San Francisco, CA, 94114
... I have worked with the FDA and related (CVM, AAFCO, EPA, etc.), the U.S. Government food, drug, cosmetic, feed and chemical regulatory agencies, include coordinating GRAS Self- Affirmations for food, feed, cosmetic ingredients and chemicals for a ...
- Apr 09
Cary, NC
... • Agile Delivery • Power BI / Tableau • ServiceNow • Jira • SAP • Oracle • TrackWise • Kneat Regulatory/Compliance: ISO,2022 NIST, FDA,21 CFR, HIPAA, GMP, LIMS, Sox, cGMPs, FDA, EU, ICH, ISO, GAMP, EudraLex, MES, Delta-V, PI data historianand CAPA. ...
- Apr 09