Quality Assurance Validation Specialist
New Jersey
An innovative research-based global pharmaceutical company is seeking a QA Validation Specialist to join their growing team at their location in the RTP area! This company has a rich pipeline of innovative molecules in various phases of development which are targeted in areas of oncology, respiratory and dermatology. They also are a leader in the generics space and impact 100 million patients annually. If you are looking to expand your career in quality with an industry leader than don't hesitate to apply!
The Quality Assurance Validation Specialist will have the following responsibilities:
This individual will provide Quality Assurance support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP). Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable GMP and regulatory requirements.
- Ability to read/interpret validation and engineering documents (protocols and reports).
- Ability to interpret and relate Validation standards for implementation and review of functional areas.
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
- Review Change Controls, Incidents, Investigations, CAPAs, SOPs.
The ideal candidate will have the following skill set:
- Bachelor's degree (B.A. / B.S.) in a scientific or engineering discipline.
- 3 years QA validation experience in the pharmaceutical industry in a cGMP setting.
- Hands on Sterile validation experience.
Compensation:
Competitive base salary + Full Medical Benefits + Relocation for the right candidate
