Complaints and Compliance Supervisor

Nutramax Laboratories•Lancaster, SC

2d•Onsite

About The Position

The Complaints and Compliance Supervisor reports to the Supplier Quality and Compliance Manager. This role is responsible for supervision and oversight of the Complaints program and site Compliance activities for Nutramax Laboratories under the guidelines outlined in the code of federal regulations 21CFR.

Requirements

B.A. or B.S. in Science or Technical field required.
Minimum of 5 years of experience in cGMP environment
Minimum of 5 years of customer service experience within an FDA regulated industry.
Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
Must be proficient Computer Software applications including MS office suite.
Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms.
Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment.
Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).

Responsibilities

Supervise Nutramax Customer Complaints and the QA Compliance department.
Monitor online reseller reviews to identify product or other issues.
Report findings to appropriate departments and assist in investigations.
Respond or otherwise address inquiries that are advanced from Customer Service or require additional investigation.
Assist Brand Protection team in counterfeit product investigations when required.
Oversee Nutramax batch record CCRs
Supervise the Non-conformance, Complaints, Audit and Supplier Modules in Qualityze.
Investigations, assessing, and closing deviations, determining impact of the issues that could affect product safety and quality.
Review, track and trend customer complaints/ AERs to ensure customer satisfaction and potential CAPAs are completed for non-conformance.
Track and trend Non-Conformances, CAPA’s, Complaints and other quality systems, assesses the risk level associated with Non-Conformances and escalates the issue to management.
Oversee product returns related to complaints.
Maintain a strong presence of the QA compliance team in Manufacturing, packaging, and laboratory operations
Develop and implement a performance indicator tracking system and reporting of departmental compliance.
Support the Nutramax change control program.
Actively support all on site audits (UL, NSF, ISO, FDA, etc.).
Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.
Train and assist internal departments to understand and comply with Quality and Compliance expectations.
Perform other assigned duties and follow verbal and written instructions issued by supervisor or designee related to meeting company goals and objectives.
Must be able to effectively communicate with other departments and function within a team environment.
Other duties as assigned
Regular attendance is required.
Enforce Safe Work Practices: It's the supervisor’s responsibility to enforce safe work practices and procedures; failure to do so is an invitation for accidents to occur.
Workers must be encouraged to identify unsafe or unhealthful workplace conditions or hazards.
Correct Unsafe Conditions: Supervisors' must take immediate steps to correct unsafe or unhealthful workplace conditions or hazards within their authority and ability to do so.
When an unsafe or unhealthful workplace condition or hazard cannot be immediately corrected, the supervisor must take temporary precautionary measures.
Supervisors must follow-up to ensure that corrective measures are completed in a timely manner to address the hazard.
Prevent Lingering Unsafe or Unhealthful Workplace Conditions or Hazards: It's the supervisor's responsibility to train and periodically remind employees of what to look for and how to correct or report unsafe conditions or hazards.
If a hazard is identified, the supervisor must act to correct.
Incidents Reporting: Immediately ensure 1st aid is provided by a ERT member and ensure there is no immediate danger to others.
Arrange additional medical treatment for the employee if necessary.
Provide emergency transportation, if needed.
Notify additional rescue/response teams if necessary.
Immediately notify EHS for employees seeking medical treatment for work related incidents.
Ensure employee completes their sections of the safety incident report.
Complete the incident report and email to Incident Response before the end of your shift.
Begin incident investigation
Secure the scene.
Keep it unchanged to accurately collect the facts.
Obtain photos if needed.
Coordinate with EHS to form a cross functional team to perform 5 WHY - Root Cause investigation – Other investigation tools may be utilized for more complicated investigations.
Corrective action(s) will be agreed upon by the cross functional team based on the root cause.
Once the investigation is complete and agreed upon by the cross functional team, email the completed investigation to Incident Reporting