- Piscataway, New Jersey, United States
- $103K–$115K per year
- 5+ years
Draft and implement Quality System documentation, author validation protocols, coordinate validation activities, provide input on equipment requirements, support technology transfer, and ensure compliance with regulatory and quality standards.
Compensation
The salary range for this position ranges from $103,000 - $115,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months.
Responsibilities
- Draft and implement Quality System documentation including SOPs and Traceability Matrix
- Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines
- Coordinate all validation activities with vendors, analyze and assemble results, and draft validation reports
- Provide input on user and/or functional requirements of current and future processing equipment
- Interface with Contract Manufacturers to ensure all relevant user and functional requirements are met
Requirements
- Engineering degree
- Pharmaceuticals degree
- Nice to have: Biological products