Quality Inspector
Somerset NJ 08873
DURATION - 6 MONTHS - ONSITE POSITION - SHIFT - MON-FRI 8:30AM - 5PM.

Quality Operational Specialist supporting manufacturing department quality-related activities. Candidate should have prior GMP inspection and documentation quality review experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail-oriented in a fast-paced multi-task environment with good oral and written communication skills and can interact with all levels of management and other supporting departments.
Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
Perform QA Room Releases, line clearances, equipment releases and AQL inspections as required.
Provide Quality Floor supports during batch manufacturing by performing routine Quality auditing.
Provide QA support to Manufacturing for clinical and commercial batches
Audit of executed Batch Records for compliance with CGMP and provide customer audit responses as required
Audit of raw materials, facility logs, release data.
Interdepartmental communication for obtaining information and audit corrections
Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities
Assist with batch investigations as required
Able to work over the weekend and stay outside business hours if required as direct by the department manager.
Assist other duties assigned by manager to support the department and business.