Quality Assurance Specialist - Kennesaw, GA

NATURE & SCOPE
The Quality Assurance (QA) Specialist reports to the QA Manager and provides independent cGMP oversight on the production floor and across manufacturing operations. The role delivers right-first-time coaching and GMP walkthroughs, reviews and approves batch production records for product disposition, and initiates or facilitates investigations of deviations and nonconformances through root-cause analysis, CAPA definition, and effectiveness verification. The QA Specialist partners closely with QA Technicians (providing guidance and mentorship) and collaborates cross-functionally with the Quality Manager (QMS and internal audit support as auditee/record owner delegate), the Quality Validations Manager (QA oversight of calibration/qualification/validation activities executed by that function, including protocol/report review and change control linkage), the QC Lab Manager (coordination on OOS/OOT/complaints data and COA verification), the Quality Specialist (specification and recipe change control alignment), and the Digital QMS Manager (accurate, timely eQMS record initiation, review, and closure). While execution of calibrations, maintenance, validations, laboratory testing, and document ownership for QMS modules resides with their respective functions, the QA Specialist verifies compliance, reviews/approves assigned quality records, escalates issues, places product or materials on hold as needed, and may recommend release, rejection, or process improvements in accordance with procedures and regulatory requirements.

MAJOR ACCOUNTABILITIES
The Quality Assurance (QA) Specialist becomes knowledgeable in applicable Federal and state requirements and cGMPs and gains competency to facilitate compliant, timely product disposition. Responsibilities include, but are not limited to:
Batch record & release readinessReview and approve batch production records (BPRs), attachments, and label reconciliations; verify required Certificates of Analysis (CoAs) and data are present and complete; recommend release or rejection per procedures.Prioritize document review to meet planned release dates; proactively escalate blockers and coordinate cross-functionally to clear them.Deviations, investigations, and CAPAInitiate or facilitate investigations for deviations/nonconformances; secure product/scope, collect evidence and samples per SOP, perform/assist in root-cause analysis, define CAPAs, and verify CAPA effectiveness; document all activities in the eQMS.Partner with QC on OOS/OOT/atypical results and with Planning/Operations/Technology to ensure impacted batches and materials are dispositioned appropriately and on time.QMS execution & documentationInitiate, review, and/or approve QMS records in the digital QMS (e.g., change control, deviations, CAPA, training acknowledgments, complaints/adverse events intake, and material/label controls) in accordance with role permissions.Ensure records are accurate, timely, and data-integrity compliant; coordinate with Document Control for effective document lifecycle management. (Document filing/archiving is owned by Document Control.)Audit/inspection readiness & continuous improvementServe as auditee/record preparer for internal, customer, and regulatory audits; maintain inspection readiness on the production floor.Identify and implement continuous improvement actions (SOP updates, error-proofing, 5S), track effectiveness, and share learnings across shifts.Cross-functional collaborationCoordinate with Planning, Operations, Technology, QC, Quality Validations, Document Control, and the Digital QMS team to ensure batches and raw materials are ready for release by required dates and issues are promptly resolved.Other duties as assigned.

Education

Minimum – 4 year university degreePreferred – 4 year university degree in science, or other related field.

Experience

Preferred two years as a quality inspector or technician in a manufacturing environmentExperience working in an FDA regulated environmentExperience in Federal and State Food Safety Regulations including HACCP and GFSIExperience with food safety and defense programsSpecific skillsAbility to take initiative to maintain confidentiality, to meet deadlines, and to work in a team environmentStrong leadership skillsMust have the ability to assess situation and develop a solutionMust have good attention to detailMust have the ability to adjust to changing work demands and priorities in a fast paced environmentEffective communication and report writing skills; legible handwriting requiredExperience 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 lift up to 50 poundsAbility to perform a standing job for a full shiftMust be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of timeAbility to differentiate subtle variances in colorFluent in English required, bilingual (Spanish) preferredMust 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:103184BR