Role Description

The Quality Coordinator is responsible for providing project management and facilitation, as well as oversight and support for the development, coordination, implementation and evaluation of Quality initiatives, primarily with Customer Complaints. Main daily work is within Customer Electronic Systems.

Reports To: Quality Customer Service Manager

Location: Remote/ Hybrid

Start Date: ASAP

Role Responsibilities

• Supports the Complaint Program throughout the ByHeart supply chain including the investigation process, root cause analysis through to the implementation of preventative measures as a result of production, complaints, and supplier events.
• Supports tracking and trending product complaints and adverse events, assessing reportability, and escalation to Management as needed.
• Daily monitoring of Customer Electronic Systems.
• System for Customer Complaints (maintains receipt, inputs, tracks and completes initial complaint responses, keeping consistent with current SOPs).
• Support Document Control (maintains procedure life cycle).
• Works closely with department team members to help organize department activities and schedules by becoming familiar with processes, procedures, and policies to ensure timely delivery of projects, investigation reports and completion of information requests.
• Works with internal customers (Parent Experience, Pharmacovigilance, Branding, Legal, Medical, Facilities) and external suppliers (Suppliers, Copackers, Logistics, 3 rd -Parties) as requested to resolve problems and to satisfy Customer Complaint needs.
• Collaborate with other functional area goals and priorities by soliciting information from those functional groups for continuous improvement and innovation.
• Understands batch record review process as indicated for Complaint Event Investigations.
• Contribute to the development of policies and procedures that support compliance with Regulatory and Quality industry standards (i.e., FDA, SQF, cGMP, and customer expectations or requirements).
• Follows Quality and Regulatory Compliance, familiar with cGMP and routinely makes decisions using cGMP/process knowledge.
• Work independently to establish priorities and completes assigned projects within timelines.
• Assist in the development of standardized customer responses.
• Assist in internal auditing program, as indicated.
• Some travel may be required to learn facility and product processes, assist in training and investigation analysis.

Skills & Qualifications

• Bachelor's degree in science (Biology, Chemistry, Engineering, other Life Science)
• Minimum two (2) years of experience in the Food Industry (Infant Formula preferred), Pharmaceutical Industry or Quality Assurance/Control
• Capable of managing projects with minimal direction
• Ability to work collaboratively and independently
• Demonstrates a high level of attention to detail and accuracy
• Understand Complaint Management processes and cGMP
• Technical writing skills
• Competent in computer systems and database entry: Office (Excel, PowerPoint, Word) and Quality related databases
• Basic statistical understanding
• Ability to travel domestically up to 10%

The minimum annual salary for this position is $75,000 and the maximum is $90,000. The salary range for performing this role outside of New York City will differ. Additionally, you will be eligible to participate in our company's equity program, plus our robust medical, dental, vision, retirement, and other benefits