Coord, Quality

Join to apply for the Coord, Quality role at SFI Health
.

• 50% – Complaint handling, investigations, documentation, and trending
• 40% – Quality operations support (GMP floor support, walkthroughs, audits, compliance activities)
• 10% – Administrative and system support

• Own the coordination and execution of domestic and global customer complaint processing in accordance with internal procedures.
• Serve as the Quality point of coordination for complaints by:
• Managing complaint intake from Customer Service tracking tools (Excel)
• Initiating and facilitating the complaint workflow as defined in standard operating procedures
• Ensuring required information is obtained, documented, and routed appropriately
• Facilitate complaint investigations under Quality leadership guidance, including:
• Collection and review of batch records, retains, and supporting documentation
• Coordination of QC testing or analysis as directed
• Entry, maintenance, and organization of investigation details, supporting information, and outcomes
• Draft and complete investigation documentation and summaries using approved templates
• Prepare and maintain complaint data to support:
• Monthly complaint trending and analytics
• Management Review reporting
• Identification of recurring issues or potential improvement opportunities
• Apply defined escalation criteria to identify and route complaints requiring regulatory review or potential adverse event evaluation, in accordance with standard operating procedures.
• Track complaint status and timelines and drive timely progression and closure in alignment with departmental performance targets.

• Provide guided on-the-floor Quality support under supervision, including:
• Participation in GMP walkthroughs and observations
• Participation in Allergen walkthroughs and observations
• Assistance with responding to routine quality questions or concerns from Operations
• Support for deviation, nonconformance, and investigation documentation
• Assist with internal audits and inspections, including preparation support, document retrieval, note-taking, and follow-up tracking
• Support document activities within the eQMS, as requested, for:
• Tracking approvals and supporting document owners
• Document release review, filing, and archival
• Cross-train to support documentation related to Certificates of Analysis (CoA), Master Manufacturing Records (MMR), Batch Production Records (BPR), Deviations, NCRs, and CAPAs
• Utilize SAP and quality systems to support traceability, document retrieval, and quality record review.

• Provide administrative support to the Quality team, including metric tracking, record organization, and support of department efficiency.
• Assist with training and awareness activities related to quality procedures, GMP expectations, and quality culture.
• Maintain compliance with safety policies, and company standards.
• Perform additional quality-related duties as assigned.

• High School Diploma or GED required.
• Some college coursework preferred.

• 1-2 years experience in Document Management, Product Life Cycle Management, or Systems deployment, ideally with experience in Quality Systems and Compliance within regulated industries.
• Experience in the Consumer-Packaged Goods, Food, Dietary Supplement, and/or Pharmaceutical Industry or other regulated (FDA, USDA) environment preferred.
• Experience with GMP or regulated environments preferred (e.g., 21 CFR 111, 117, 210 or 211).

• Detail oriented, strong communication skills, and ability to work independently.
• Ability to follow established procedures with a strong sense of urgency and sound judgment regarding escalation.

• Must have a working knowledge of Microsoft Word, Excel, and.

• Supervisory Responsibilities:
  
  None.
• Work Environment:
  Office and Manufacturing.
• Physical Demands:
  Essential job functions require walking, bending, the ability to lift 10 lbs. Secondary functions require walking, lifting, climbing, repetitive motion, standing up to 8 hours per day; lift up to 50 lbs.
• Travel:
  Less than 5%.
• Career Path (Optional):
  Quality Specialist, Tech II Operations, QC Analyst.

Pay: $23-$25 DOE

Hours:

M-F 8:00AM-4:30PM (FLEX Start)

• 401(k)
• 401(k) Matching
• Health Insurance
• Health Savings Account
• Dental Insurance
• Vision Insurance
• Tuition Reimbursement
• Paid Time Off
• 10 Paid Holidays

• Seniority level:
  Entry level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industries:
  Retail Health and Personal Care Products