93109BRJob Title:Quality SpecialistDepartment/Function:Operations: Manufacturing, Production, Maintenance, UtilitiesJob Description:Quality Specialist - Decatur ILThe 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 Management
Assist in implementing, verifying, and continually improving the QMS system and associated programs.
Serve on the Food Safety and HACCP Teams
Function as a releasing agent for product release
May serve on project teams.
Performs other duties as assigned.
Education
Minimum – Bachelors Degree in Engineering, Chemistry, or equivalent
Experience
Minimum - 1+ years quality experience in an FDA regulated facility; 1+ years CAPA/NC related experience
Preferred - Experience in Federal and State Food Safety Regulations including HACCP and GFSI
Specific Skills & Abilities
Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment
Strong leadership skills
Strong 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 solutions
Must have excellent attention to detail
Must have the ability to adjust to changing work demands and priorities in a fast paced environment
Experience with Microsoft Office products with an emphasis on Excel
Strong analytical experience
Ability to learn new technologies quickly
Results driven, strong work ethic
Strong organizational and time management skills
Ability 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 time
Ability to work flexible schedules including nights and weekends
Fluent in English required, bilingual (Spanish) preferred
Must possess a valid US driver’s license
Excited 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:93109BRReq/Job ID:93109BRCity:DecaturState:IL - IllinoisRef ID:#LI-AM1:About ADMAt ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.:#LI-Onsitet:#IncludingYouDiversity, equity, inclusion and belonging are cornerstones of ADM’s efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments — environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together.We are committed to ensuring all qualified applicants receive consideration for employment regardless of race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.We welcome everyone to apply, especially those individuals who are underrepresented in our industry, as we strive to ensure our workforce represents the world that we help to feed: people of color, women, gender non-conforming, LGBTQIA+, veterans and persons with disabilities. For more information regarding our efforts to advance Diversity, Equity, Inclusion & Belonging, please visit our website here: Diversity, Equity and Inclusion | ADM. (https://www.adm.com/en-us/culture-and-careers/diversity-equity-inclusion/):Benefits and PerksEnriching the quality of life for the world begins by taking care of our colleagues. In addition to competitive pay, we support your diverse needs with a comprehensive total rewards package to enhance your well-being, including:
Physical wellness – medical/Rx, dental, vision and on-site wellness center access or gym reimbursement (as applicable).
Financial wellness – flexible spending accounts, health savings account, 401(k) with matching contributions and cash balance plan, discounted employee stock purchasing program, life insurance, disability, workers’ compensation, legal assistance, identity theft protection.
Mental and social wellness – Employee Assistance Program (EAP), Employee Resource Groups (ERGs) and Colleague Giving Programs (ADM Cares).
Additional benefits include:
Paid time off including paid holidays.
Adoption assistance and paid maternity and parental leave.
Tuition assistance.
Company-sponsored training and development resources, such as LinkedIn Learning, language training and mentoring programs.
Benefits may vary for bargained locations, confirm benefit eligibility with your recruiter.
