Senior Quality Assurance Inspector

Payrate: $36 - $41/hr.

Summary:

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.

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
• 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.
  
  

Education or Equivalent Requirements:

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

Knowledge/Skills Requirements:

• 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.
• Candidate must have detail oriented with effective oral and written communication skills.
  
  

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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