Quality Control Specialist - Kennesaw, GA

Job Description

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.

• 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.

• 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.

Required Skills:

• 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