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Quality Assurance Specialist
2 months ago
Job Description Quality Assurance Specialist - Kennesaw, GAThis is a salaried exempt level position.Position Summary:Join our team as a Quality Assurance Specialist and play a pivotal role in ensuring the excellence of our Quality Assurance Systems. In this dynamic position, you'll collaborate with the Quality Assurance Manager to maintain high standards, including reviewing production records, conducting root cause analyses, and implementing corrective actions. You'll support the production floor with adherence to cGMPs and documentation accuracy while working closely with various teams, including Document Control, Quality Control, and Production. This role offers the opportunity to develop expertise in Federal regulations and cGMPs, contributing to the successful release of products and the overall success of our quality programs.Position Responsibilities:Obtain PCQI certification to human food as per applicable laws.Perform release authorization by reviewing and approving certificates of analysis, batch records, master manufacturing records, and associated non-conformance and deviations.Conduct root cause analysis and evaluate processes to address complex non-conformances and deviations; maintain complete records.Ensure all non-conformance dispositions and corrective actions comply with customer specifications and applicable regulations.Communicate disposition decisions effectively and ensure implementation of CAPA.Liaise with stakeholders, including customers, on disposition decisions and corrective actions.Collect and manage samples for laboratory testing, validation, and trending.Assist with specification changes and perform laboratory analysis on validation samples as needed.Support and execute validation and verification activities, ensuring timely completion.Oversee the scheduling of document reviews to align with product release dates.Coach and mentor manufacturing staff on documentation practices and compliance.Collaborate with Production and other teams to resolve documentation issues and implement continuous improvement initiatives.Provide training on Quality System and Quality Assurance procedures.Work with Planning/Product Development on non-conforming materials disposition.Assist with the development and review of Standard Operating Procedures and other process documentation.Perform Quality system verifications, such as lighting and pressure differential verifications. Job Requirements:Minimum of a 4-year university degree or 5+ years of relevant industry experience; preferred degree in science, biotechnology, or related field.Two years of experience as a quality inspector or technician in a manufacturing environment preferred; a background in in FDA-regulated environments, experience with food safety and defense programs, and familiarity with Federal and State Food Safety Regulations, including HACCP and GFSI.Proficient in Microsoft Office, particularly Excel.Bilingual (English and Spanish) preferred.Strong leadership, analytical skills, and attention to detail.Effective communication and report writing skills; legible handwriting required.Ability to work in a fast-paced environment and learn new technologies quickly.Ability to handle mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Ability to lift up to 50 pounds, perform standing tasks for full shifts, and engage in various physical activities such as walking, bending, kneeling, stooping, climbing, reaching and grasping for varying periods of time. Must be able to differentiate subtle color variances.Must possess a valid US driver's license.Excited about this role but don't meet every requirement listed? Studies show that often applicants will self-select out if they don't check every box. 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 checkREF:89104BR
