Quality Assurance Specialist - Kennesaw, GA

Archer Daniels Midland Company•Kennesaw, GA

51d•Onsite

About The Position

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:

Requirements

Minimum - 4 year university degree
Ability to take initiative to maintain confidentiality, to meet deadlines, and to work in a team environment
Strong leadership skills
Must have the ability to assess situation and develop a solution
Must have good attention to detail
Must have the ability to adjust to changing work demands and priorities in a fast paced environment
Effective communication and report writing skills; legible handwriting required
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 lift up to 50 pounds
Ability to perform a standing job for a full shift
Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of time
Ability to differentiate subtle variances in color
Fluent in English required
Must possess a valid US driver's license.

Nice To Haves

Preferred - 4 year university degree in science, or other related field.
Preferred two years as a quality inspector or technician in a manufacturing environment
Experience working in an FDA regulated environment
Experience in Federal and State Food Safety Regulations including HACCP and GFSI
Experience with food safety and defense programs
bilingual (Spanish) preferred

Responsibilities

Review 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.
Initiate 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.
Initiate, 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.)
Serve 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.
Coordinate 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.