Quality Systems Specialist

Category:

Life Science

Employment Type:

Contract To Hire

Reference:

BH-388292

Yoh is seeking a Quality Systems Specialist
for our personal care client here in St. Louis, Missouri. The primary role of the Quality Systems Specialist is to develop documentation and investigate facility systems and processes to ensure compliance with FDA regulations as well as develop and monitor change control processes, variances and investigations for continuous process control.

Shift:
Monday - Friday, 9AM - 5PM (Onsite)

Essential Duties and Responsibilities:

• Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done; must respond timely to deliver quality investigations and thorough CAPAs
• Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess system and processes.
• Assist in GMP and GDP training of new personnel.
• Participate in internal audits
• Create or modify SOPs and work instructions. Recommend changes to batching instructions.
• Ensure GMP required documentation is following governmental regulations such as FDC.
• Maintain quality system of Process Variance Reports (PVR)
• Generate Annual Product Reviews (APR)
• Customer Complaint Investigations
• Develop or assist with process control procedures and automation specifications, where necessary, to ensure on-going compliance.
• Maintain Quality attributes in Customer Specification portals
• Define and / or improve upon systems and processes
• Assist in the maintenance of the Validation Master Plans
• Monitor and interpret the Federal Register and other sources that provide information on laws pertaining to Food, Drugs and Cosmetic Industries.
• Advise and inform management on validation issues.
• Read and understand Piping and Instrumental Diagrams and create Process Flow Diagrams.
• Evaluate data from current processes to recommend improvements, cost effectiveness and production quality.
• Perform Statistical Process Analysis to evaluate process control.
• Perform Site Acceptance Tests and Factory Acceptance Tests prior to equipment startup, as required
  
  

• Bachelor's Degree required in a related Science or Engineering field (required)
• 2 - 5 years' experience in a GMP / Manufacturing environment
• Knowledge of current GMPs.
• Experience in developing documentation
• Quality investigations, CAPA, Deviations, internal audits (required)

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities