Senior Quality Assurance Inspector at The Fountain Group
Somerset, NJ
About the Job
We are a national staffing firm and are currently seeking a QA Inspector for a prominent client of ours. This position is located in Somerset, NJ Details for the position are as follows:
If you are interested in hearing more about the position, please respond to this posting with your resume attached
- $41hr based on previous experience.
- This is an onsite role. - SHIFT - MON-FRI 8:30AM - 5PM.
- 6+ month contract - (potential to extend or convert based on performance & budget).
- 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.
- Good understanding of compliance regulations and audit techniques.
- Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
- Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical manufacturing
- Good mathematical skills
- Safety procedures associated with department.
- Read and understand MSDS requirements and restrictions.
- Understand procedures related to document control, Quality Assurance and this job function.
- Candidate must have ability to work effectively under high pressure on multiple projects.
If you are interested in hearing more about the position, please respond to this posting with your resume attached