Quality Systems Specialist

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. 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) Education Requirements: 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 Quality Systems such as CAPA, Deviation or Investigations. Estimated Min Rate: $25.00 Estimated Max Rate: $30.00 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 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 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: #J-18808-Ljbffr Yoh Services LLC