Clinical Quality Assurance Career Research and Resources
SRG Consulting
Perform consulting tasks for various regulated companies within the pharmaceutical and biotech industries involving validation, SOP development, business process development and training
Avg. Salary: $110,000 · Company Rank: Not Available
Amgen Inc.
Directed a cross functional team through validation and implementation of enterprise computer systems , lead an all sites governance team for computer systems validation, and best business practices for world wide implementation. Pioneered FDA readiness inspection process and training program.
Avg. Salary: $110,000 · Company Rank: Not Available
Wyeth Pharmaceuticals Inc.
Harmonized a global computer validation process, updated SOPs, and instituted a global training program. Managed a FDA mandated phased verification process for consent decree remediation and enterprise systems verification utilizing a third party vendor. Designed a Part 11 assessment process for all legacy computer systems to allign with FDA.
Avg. Salary: $110,000 · Company Rank: Not Available
Schering-Plough Corp.
Managed and developed a world wide auditing and vendor management program for all software vendors and systems integrators in the manufacturing environments.
Avg. Salary: $110,000 · Company Rank: Not Available
Daiichi Pharmaceutical Corp.
Developed CMC sections of a new drug submission related to validation, process development, sterilization, packaging and labeling for a new antimicrobial compound for the Canadian market. Also involved with serious adverse events involving phase III clinical materials.
Avg. Salary: $110,000 · Company Rank: Not Available
Merck
In the Global Clinical Supplies Master Planning group, tracked progress of clinical supply chain jobs and prepared operational metrics. Worked closely with upper management to ensure alignment with overall project planning.
Avg. Salary: $85,000 · Company Rank: Not Available
Haemoscope Corporation
Liaison between Product Development and Manufacturing, coordinating quality testing of consumables and transfer to manufacturing of supplies needed for customer shipments in a strict regulatory environment. • Tracked R&D budget on a monthly basis and forecasted future costs and shipments of medical device consumables. Responsible for maintaining communication with primary investigators to determine needs of clinical trial...
Avg. Salary: $85,000 · Company Rank: Not Available
Schering-Plough
Short term contract in Clinical Manufacturing assisting QA in reviewing batch records and providing project management support.
Avg. Salary: $85,000 · Company Rank: Not Available
Schering-Plough
cGMP specialist involved in packaging, labeling and distribution of clinical trial supplies using CRO manufacturers (Almac, Fisher, Acculogix, Aptuit, Patheon). Focused on large, multi-country Phase II-III studies. Ensured regulatory compliance of clinical packaging materials by developing packaging plan, preparing pre-execution documents, interfacing with vendors to resolve quality issues, processing samples and inventory...
Avg. Salary: $85,000 · Company Rank: Not Available
Western Illinois University
teaching labs, assisting undergraduate students in lab. Assisting professors and assistant professors in class teaching.
Avg. Salary: $12,000 · Company Rank: Not Available
