What are the responsibilities and job description for the Senior Quality Assurance Inspector position at System One?
Title: Senior Quality Assurance Inspector
Location: Somerset NJ
Hours / Schedule: Monday - Friday, 8:30 am to 5:00 pm, onsite (scheduled overtime and occasional weekends)
Type: Temp
Education:
High school diploma or equivalent (GED) with 8 years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing
Responsibilities:
• 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
Requirements
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High school diploma or equivalent (GED) with 8 years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing
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Good understanding of compliance regulations and audit techniques.
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Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
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Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical
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Good mathematical skills
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Safety procedures associated with department.
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Read and understand MSDS requirements and restrictions.
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Understand procedures related to document control, Quality Assurance and this job function.
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Candidate must have ability to work effectively under high pressure on multiple projects.
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Candidate must have detail oriented with effective oral and written communication skills.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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