GMP / Quality Compliance Supervisor

iHerb•Easton, PA

4d•Onsite

About The Position

The GMP / Quality Compliance Supervisor supports and maintains the execution of the quality and compliance programs at a fulfillment center. This role focuses on implementing and maintaining Good Manufacturing Practices (cGMPs) throughout the fulfillment process, from receiving to shipping. The GMP / Quality Compliance Supervisor plays a key role in monitoring quality compliance, performing inspections, supporting audits, assisting in training, and ensuring consistent documentation and operational adherence to FDA and NSF regulatory standards. The position will also support all relevant Compliance initiatives and functions as needed.

Requirements

Solid knowledge of cGMPs and relevant regulations for products stored and fulfilled at site including Dietary Supplements, Food, Cosmetics and OTC Drugs
Proven experience in leading audits, managing CAPA processes, and overseeing cGMP compliance in a fulfillment facility environment.
Ability to make administrative and procedural decisions and judgments
Ability to foster a cooperative work environment
Ability to plan, develop and coordinate multiple projects
Strong problem-solving abilities with a hands-on-approach to addressing quality issues.
Experience with auditing and ensuring compliance with both internal and external quality standards
Strong organizational and managerial skills.
Strong communication skills – written, oral, reading and understanding, with the ability to present data clearly and concisely.
Ability to work extended hours as necessary
Ability to provide guidance and direction
PCQI (Preventive Controls Qualified Individual) certification
7+ years in a quality control or GMP-regulated role, preferably within a fulfillment, manufacturing, or distribution environment.
Associate’s degree or equivalent experience required; Bachelor’s degree in a relevant field preferred or equivalent work experience
Able to identify, troubleshoot and resolve problems quickly using sound judgment, poise and diplomacy.
Ability to use judgment and reasoning skills, and determine when to escalate issues, as required, in a timely manner.

Nice To Haves

Six Sigma certification preferred
Bachelor's degree in a relevant field preferred or equivalent work experience

Responsibilities

Enforce cGMP compliance across the entire fulfillment lifecycle—from goods receipt through final shipment of finished products.
Support the development and maintenance of SOPs and ensure team adherence to operational and regulatory procedures.
Conduct routine facility inspections, cGMP audits, and follow up on implementation of corrective and preventive actions (CAPAs).
Maintain audit readiness for internal, FDA, and NSF inspections and other government authority inspection and audits by ensuring proper documentation and facility conditions.
Maintain up-to-date and organized quality records, including inspection reports, sanitation logs, training documentation, and temperature logs and other quality and cGMP related documentation.
Supervise inspections of received, in-process, and outbound orders to verify compliance with quality standards and regulatory requirements.
Handle investigations of internal quality issues, supporting root cause analysis and tracking corrective measures.
Coordinate and deliver GMP and quality-related training for fulfillment team members, including during onboarding and refreshers.
Monitor and document conditions of the quarantine and retention areas and support segregation of non-compliant materials.
Assist in pest control, sanitation, calibration, and other support programs that uphold GMP facility requirements.
Collaborate with the operations team to resolve fulfillment, packaging, or storage issues that could affect product integrity, quality, or customer satisfaction.
Supervise product recall protocols by ensuring appropriate documentation and product handling steps are followed.
Encourage and reinforce a culture of quality, safety, and continuous improvement within the fulfillment team.
Preparation of quality data for internal reporting and provide input on trends or recurring issues.
Participate in cross-functional projects and perform other quality or compliance duties as directed by leadership.