Job Title: Senior Quality Specialist
Reports to: Director Quality & Regulatory
Location: Blue Bell, PA [hybrid – minimum 3 days in office per week]
POSITION OVERVIEW
The Senior Quality Specialist is responsible for supporting and maintaining the organization’s Quality Management System (QMS) and ensuring product quality, regulatory compliance, and continuous improvement across operations. This role serves as a key quality partner to internal stakeholders, manages critical quality programs and records, and supports certification, audit, and customer quality activities.
Key Responsibilities:
- Support and maintain the Quality Management System (QMS), ensuring product quality, regulatory compliance, and continuous improvement across operations.
- Manage and maintain quality documentation and systems, including product specifications, version control, the Quality Systems Manual, and the Q&R document repository ensuring alignment with regulatory and industry standards.
- Oversee shelf life and retain sample programs, including sample retesting, documentation, review, and coordination of aged inventory requests to support shelf‑life extensions and minimize potential losses.
- Conduct bulk tank monitoring and oversee bulk & packaged product receipt, release, and quality controls to verify materials meet established quality and safety requirements prior to use or distribution; serve as backup support for the COA process as needed.
- Lead and support quality system activities including change control, product quality investigations, nonconformance reports (NCRs), corrective and preventive actions (CAPAs), and KPI tracking to identify trends and drive continuous improvement.
- Participate in and support internal, customer, and third‑party audits, including oversight of certification programs such as USDA Organic and facilitation of annual audit activities.
- Partner with internal stakeholders and customers to provide guidance and training on quality requirements, documentation, onboarding, and issue resolution, including support through the Freshdesk Customer Portal and QR onboarding for new employees.
Qualifications & Experience
- Minimum of five years of experience in quality or regulatory positions is required, along with a bachelor's degree in quality, chemistry, biology, or a related discipline.
- Strong knowledge of quality systems, document control, CAPA, NCRs, and audit processes, with proficiency in document management systems and customer portals.
- Strong organizational, analytical, and communication skills; able to handle multiple priorities in a fast-paced, cross-functional setting.
- Advanced proficiency in Microsoft Excel and strong overall computer skills, enabling efficient data analysis, reporting, and quality system management.
Key Competencies
- Exceptional attention to detail and documentation accuracy.
- Strong problem-solving and root cause analysis skills, with a continuous improvement mindset.
- Effective communicator with demonstrated stakeholder collaboration and regulatory, quality system expertise.
