Quality System Specialist

Pay range: 20-24/hr
*depending on experience

Key Responsibilities
Quality Systems & Compliance:
• Assist in leading and coordinating the resolution and completion of Deviations, CAPAs, and batch record backlogs, collaborating with functional teams or assignees to drive timely completion.
• Partner with cross-functional teams to propose and implement process improvements for better visibility, accountability, and sustainability of quality systems, with the goal of avoiding future backlogs.
• Support the management and tracking of Deviations, CAPAs, Batch Records, Change Controls, and related quality records to ensure timely follow-up and effectiveness.
• Support preparation for internal and external audits and inspections and 24/7 inspection readiness.
Training & Quality Culture:
• Coordinate training activities, ensuring personnel are trained on relevant SOPs, policies, and quality procedures.
• Assist in building a culture of quality awareness, accountability, and adherence to procedures across functions.
• Assist in establishing process to maintain accurate training records and escalate gaps to management.
Documentation, Specifications & SOP Management:
• Assist in updating raw material specifications, including contacting vendors, gathering data, and revising controlled documents.
• Develop job aids, work instructions, and flowcharts to supplement SOPs, making procedures easier to understand and execute consistently.
• Ensure good documentation practices (GDP) are followed across the site.
• Support authoring, reviewing, and updating SOPs to reflect current cGMP requirements and company policies.
• Maintain organized, accessible records for traceability and compliance and remove superseded or draft versions of documentation.
Inventory & Warehouse Support:
• Partner with warehouse staff to promote organization, labeling, and adherence to inventory procedures.
• Assist in improving structure and documentation for materials/QA chemical inventories
• Support visibility of material disposition, including traceability of materials and products placed on hold.
Third-Party Oversight:
• Coordinate and track testing performed by contract laboratories, ensuring results are received, reviewed, and documented in a timely manner.
• Maintain visibility of raw material and product testing status, escalating delays or issues as needed.
Administrative & Coordination Duties:
• Develop and maintain trackers, logs, and dashboards in Microsoft Excel/Word/PowerPoint for quality system metrics and reporting.
• Support cross-functional communication to ensure timely follow-up on quality-related tasks and commitments.
• Provide general coordination support to the site Quality Team in daily operations.
Qualifications & Requirements
• Bachelor’s degree in a scientific or technical discipline preferred (e.g., Chemistry, Biology, Quality, Engineering). Equivalent experience considered.
• 2–5 years of experience in a GMP-regulated manufacturing or consumer health/OTC environment.
• Strong knowledge of quality systems (Deviations, CAPA, Change Control, Training, Documentation, Batch Records).
• Experience supporting raw material specifications, SOP management, and training materials development preferred.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to create reports, trackers, and presentations. Power BI skill is preferred.
• Demonstrated ability to bring structure and accountability in environments requiring process discipline.
Key Competencies
• Organization & Structure: Ability to establish and maintain order in a fast-paced, dynamic environment.
• Accountability: Ensures follow-through on commitments and escalates risks proactively.
• Communication: Clear, professional, and collaborative approach with internal and external stakeholders.