Quality Systems Specialist

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 Instrumentation 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

Education & Experience Requirements

What'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 :

Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https : / / www.yoh.com / applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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