Quality Specialist - Decatur IL

The QA Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas are in compliance, and will train on and gain competency in activities as they relate to quality and adherence to various standards.  Specific responsibilities include but are not limited to the following:Review new or revised Standard Operating Procedures (SOPs) and forms for compliance with applicable regulations.Assist other departments in the development, revision, and preparation of SOPs and forms in accordance with policies, regulations and protocols.Owns and updates site level cGMP documentation.Performs audit preparation activities and assists with hosting audits.Identifies root cause and CAPAs associated with audit findings and manages communications with auditing bodies.Work with internal and external auditors; may be required to act as spokesperson on behalf of company.Participate in customer complaint investigations, managing associated CAPAs, and reporting of metrics.Advise and assist in the establishment of calibration protocols and maintenance records in accordance with cGMP, cGLP and/or regulatory requirements.Assist in the review, trending, and management of equipment, calibration, and maintenance records.Advise and assist with development and execution of validation and qualification of methods, processes, and equipment; Perform validations as required.Carry out non-conformance, and OOS investigations for production  ensuring proper identification of failure mode, root cause, and corrective/preventive action as well as clearly written summaries.Conduct CAPA and deviation investigations.Provide summaries and reports of deviation and nonconformances and other quality system documentation relevant to manufacturing.Gathers and reports data and trending of Quality Objectives, Y-Chart metrics, QMS, and other quality data.Generate and present reports on departmental activities, efficiencies, and deficiencies.Provide guidance and train others on Quality System and Quality Assurance procedures.Perform IQ OQ PQs as required for production equipment.May be called upon to review data, protocols, reports, technical specifications, and spreadsheet validations.Evaluate temperature mapping of the warehouse/production facilities and prepare reports.Initiate action reports or deviation reports for applicable nonconformances.Provide quality review and investigation on OOS stability results and communicate recommendations to Quality ManagementAssist in implementing, verifying, and continually improving the QMS system and associated programs.Serve on the Food Safety and HACCP TeamsFunction as a releasing agent for product releaseMay serve on project teams.Performs other duties as assigned.EducationMinimum – Bachelors Degree in Engineering, Chemistry, or equivalentExperienceMinimum - 1+ years quality experience in an FDA regulated facility; 1+ years CAPA/NC related experiencePreferred - Experience in Federal and State Food Safety Regulations including HACCP and GFSISpecific Skills & AbilitiesAbility to take initiative, maintain confidentiality, meet deadlines, and work in a team environmentStrong leadership skillsStrong knowledge of current quality systems requirements and implementation techniques.Superior communication and analytical skills, plus demonstrated skills to handle a variety of assignments simultaneously.Customer-advocate to ensure on time task completion.Requires excellent written and verbal communications.Must have the ability to assess situations and develop solutionsMust have excellent attention to detailMust have the ability to adjust to changing work demands and priorities in a fast paced environmentExperience with Microsoft Office products with an emphasis on ExcelStrong analytical experienceAbility to learn new technologies quicklyResults driven, strong work ethicStrong organizational and time management skillsAbility to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of timeAbility to work flexible schedules including nights and weekendsFluent in English required, bilingual (Spanish) preferredMust possess a valid US driver’s licenseExcited about this role but don’t think you meet every requirement listed? We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.

ADM requires the successful completion of a background check. 

REF:93109BR