Title: QA Specialist
Department: Validation/Qualification
Location: Somerset, New Jersey (ONSITE, must be local)
Length: 6 month contract to hire
This role is mainly responsible for providing quality oversight and ensure that activities regarding validation and qualification are following all protocols, including FDA regulations and other industry guidelines.
Key Responsibilities:
- Provide Quality oversight for validation and qualification of facilities and utilities, as well as equipment, manufacturing, packaging, computer systems, and cleaning processes
- Ensure that procedures and policies for Validation and Qualification systems are consistent with FDA regulations and site guidelines
- Be in charge of reviewing different plans, protocols, risk assessments, and reports related to validation and qualification
- Work alongside SMEs from different functional departments to ensure that validation and qualification activities are consistent with requirements of site and company SOPs
- Information acquired during validation and qualification is applied to batch records and SOPs to ensure that processes are accurately maintained
- Perform other duties assigned within the department
Qualifications:
- Bachelor's degree required; Master's degree preferred
- Minimum of 5 years of biotech/pharmaceutical industry experience in Quality space
- Experience working in an FDA regulated environment. Knowledgeable with guidelines related to pharmaceutical drug manufacturing
- Prior experience with process and method validation or equipment and facility qualification
- Familiar with Quality Management System, ERP system, Microsoft Office
- Team player, communicating and collaborating with cross-functional teams
If interested, do not hesitate! Apply now!
