Quality Specialist
- Saint Louis, MO
- Permanent
- Full-time
Shift: Monday - Friday, 9AM - 5PM
Contract: 6 months (with possibility to convert)Summary:
The primary role of the Quality 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.Essential Duties and Responsibilities:
- Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.
- Present for work when scheduled is a mandatory function.
- Your compliance and enforcement of all company safety rules procedures and guidelines is essential. Reporting of safety issues is mandatory.
- Assist in the maintenance of the Validation Master Plans
- Coordinate resources and communicate project progress, applying project management tools and techniques effectively for multiple projects
- Ensure GMP required documentation is following governmental regulations such as FDC.
- 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.
- Define and / or improve upon systems and processes
- Maintain quality system of Process Variance Reports (PVR)
- Generate Annual Product Reviews (APR)
- Customer Complaint Investigations
- Maintain Quality attributes in Customer Specification portals
- Read and understand Piping and Instrumental Diagrams and create Process Flow Diagrams.
- Develop or assist with process control procedures and automation specifications, where necessary, to ensure on-going compliance.
- Evaluate data from current processes to recommend improvements, cost effectiveness and production quality.
- 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.
- Create or modify SOPs and work instructions. Recommend changes to batching instructions.
- Perform Statistical Process Analysis to evaluate process control.
- Perform Site Acceptance Tests and Factory Acceptance Tests prior to equipment startup, as required.
- Review final validation protocols for facilities systems (IQ/OQ/PQ), processes (PV), and cleaning validations (CV)
- Perform all other duties as assigned.
- Bachelor’s Degree required in a related Science or Engineering field.
- Knowledge of current GMPs.
- A minimum of two to five (2-5) years’ experience in manufacturing of food, cosmetics or pharmaceutical products required. Experience with filtration, water pretreatment and reverse osmosis water systems; CIP/SIP systems and processes; steam, cooling water, batch mixing, sanitary piping systems; understanding of PLC functions preferred. PLC Programming knowledge is preferred. Ability to troubleshoot process and utility equipment required.
Estimated Max Rate: $32.00What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- 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