Quality Control Specialist - Kennesaw, GA

Archer Daniels MidlandKennesaw, GA
10hOnsite

About The Position

Quality Control Specialist, Kennesaw GA. Job Responsibilities: The Quality Control Specialist provides direct support to the continuous improvement of the laboratory initiatives of the QMS. The Quality Control Specialist, with guidance from the Quality Control Laboratory Manager, ensures the quality of various systems throughout the department. The Quality Control Specialist will also help assess and develop method and equipment validations associated with testing within the QC Laboratories The Quality Control Specialist is responsible for gaining strong knowledge of Federal and regulatory agency requirements, cGMPs, and standards/certification expectations to ensure full compliance across all laboratory operations. This role will train on and develop competency in all quality‑related activities, supporting adherence to applicable regulations and internal policies. Key areas of responsibility include, but are not limited to, the following: SOPs, Lab Methods & Forms Develop, revise, and prepare SOPs, laboratory methods, and forms to support lab operations. Conduct periodic reviews of SOPs, Lab Methods, and Forms to ensure compliance with current regulations, standards, and internal practices. Submit change controls as needed. Maintain and update calculation worksheets associated with laboratory methods, where applicable. Validations / Verifications Ensure laboratory equipment is properly validated or verified and maintained in a validated state. Ensure laboratory methods are validated or verified according to requirements and kept current. Assess, develop, and execute validations and qualifications for laboratory methods, processes, and equipment. Review and approve laboratory notebooks, validation protocols, reports, technical specifications, and spreadsheet validations. Maintenance & Calibrations Establish and maintain calibration protocols and maintenance records in compliance with cGMP, cGLP, and relevant regulatory standards. Schedule and coordinate calibration activities to ensure equipment remains within calibration due dates. Oversee equipment maintenance and repairs, including management of third‑party service providers. Manage all equipment, calibration, and maintenance records according to internal procedures. Ensure proper use and documentation of maintenance logs. Laboratory Investigations Conduct Laboratory Error Investigations, identifying failure modes, root causes, and corrective/preventive actions (CAPAs), and prepare clear written summaries. Perform investigations into non‑conformances and process/equipment deviations with appropriate root-cause analysis and CAPA documentation. Execute CAPA investigations and ensure timely implementation and verification. Create deviation reports, nonconformance documentation, and related quality system records. Provide training to laboratory personnel on corrective and preventive actions as needed. Data Management Support Lab Management with data gathering and trending for Quality Objectives, QMS metrics, and other quality system indicators. Prepare and present reports summarizing departmental activities, trends, and efficiencies. Assist with organizing, filing, and archiving laboratory documents and data. Other Responsibilities Deliver guidance and training on Quality Systems, Quality Assurance processes, and related procedures. Develop specifications for laboratory reagents, supplies, and materials in alignment with ISO standards. Coordinate stability studies and manage reporting of results. Support internal and external audits Serve as a participant on project teams as assigned. Act as a delegate for Lab Administration and Quality Assurance Specialists when needed. Perform other duties as assigned.

Requirements

  • 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
  • Minimum – 4 year university degree
  • Minimum - 1+ years quality experience in an FDA regulated facility.

Nice To Haves

  • Preferred – 4 year university degree in science, biotechnology, or other related field.
  • Preferred - Experience in Federal and State Food Safety Regulations including HACCP and GFSI
  • Preferred - Experience with food safety and defense programs

Responsibilities

  • Develop, revise, and prepare SOPs, laboratory methods, and forms to support lab operations.
  • Conduct periodic reviews of SOPs, Lab Methods, and Forms to ensure compliance with current regulations, standards, and internal practices.
  • Submit change controls as needed.
  • Maintain and update calculation worksheets associated with laboratory methods, where applicable.
  • Ensure laboratory equipment is properly validated or verified and maintained in a validated state.
  • Ensure laboratory methods are validated or verified according to requirements and kept current.
  • Assess, develop, and execute validations and qualifications for laboratory methods, processes, and equipment.
  • Review and approve laboratory notebooks, validation protocols, reports, technical specifications, and spreadsheet validations.
  • Establish and maintain calibration protocols and maintenance records in compliance with cGMP, cGLP, and relevant regulatory standards.
  • Schedule and coordinate calibration activities to ensure equipment remains within calibration due dates.
  • Oversee equipment maintenance and repairs, including management of third‑party service providers.
  • Manage all equipment, calibration, and maintenance records according to internal procedures.
  • Ensure proper use and documentation of maintenance logs.
  • Conduct Laboratory Error Investigations, identifying failure modes, root causes, and corrective/preventive actions (CAPAs), and prepare clear written summaries.
  • Perform investigations into non‑conformances and process/equipment deviations with appropriate root-cause analysis and CAPA documentation.
  • Execute CAPA investigations and ensure timely implementation and verification.
  • Create deviation reports, nonconformance documentation, and related quality system records.
  • Provide training to laboratory personnel on corrective and preventive actions as needed.
  • Support Lab Management with data gathering and trending for Quality Objectives, QMS metrics, and other quality system indicators.
  • Prepare and present reports summarizing departmental activities, trends, and efficiencies.
  • Assist with organizing, filing, and archiving laboratory documents and data.
  • Deliver guidance and training on Quality Systems, Quality Assurance processes, and related procedures.
  • Develop specifications for laboratory reagents, supplies, and materials in alignment with ISO standards.
  • Coordinate stability studies and manage reporting of results.
  • Support internal and external audits
  • Serve as a participant on project teams as assigned.
  • Act as a delegate for Lab Administration and Quality Assurance Specialists when needed.
  • Perform other duties as assigned.

Benefits

  • 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.
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