Location: Somerset,NJ, USA
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.