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

High school diploma or equivalent (GED) with 8+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing 

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   

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. 

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. 

#M3

 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.