As a Quality Specialist Consultant, you will play an important role in supporting clients and in interactions across the organization. You will be responsible for ensuring that our clients’ businesses are in compliance with Good Manufacturing Practices (GMPs). We will expect you to be well versed in the processes adhered to by consumer healthcare businesses to maintain regulatory compliance. You must put a high value on effectively communicating compliance policies and processes as well as recommendations and solutions to quality problems to people in both business roles and in quality roles.
You have high expectations for yourself and your career, so does ISS. Imagine what we will achieve together.
Write and/or revise Standard Operating Procedures (SOPs)
Lead investigations into consumer complaints and make recommendations for product improvements
Review and release products for commercial distribution
Coordinate stability and other quality testing programs
Address and escalate, if needed) quality issues that arise
Assist in Quality Audits of manufacturing facilities, if required
Develop and implement Corrective/Preventive Actions (CAPA)
And other quality related projects as required by client
This is an office position in Morristown, NJ - lab technicians and telecommuters need not apply.
The ideal candidate is inquisitive, ambitious, hardworking and has a strong interest in the healthcare field, including the following characteristics:
4 Year degree in a life science or related field
A background in Good Manufacturing Practices for drugs, dietary supplements or medical devices
Keen interest in quality in the healthcare industry
Proficient with Word, Outlook, Excel, and PowerPoint
Eagerness to work independently and in teams in a fast-paced environment
Extremely comfortable reviewing and interpreting scientific data and developing practical solutions to quality related issues
Ability to leverage resources and continually learn and expand knowledge base
Passion for helping clients maintain regulatory compliance and delivering actionable solutions to quality problems
Innovative Science Solutions (ISS), a Cello Health business, is a leading scientific consulting firm serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of skilled scientific and regulatory consultants that deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, ISS integrates strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.