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• Maintain organized, accessible records for traceability and compliance and remove superseded or draft versions of documentation.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.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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