GMP Quality Compliance Supervisor
Easton, PA - USA
Job Summary
For A Better You
At iHerb we believe that living a healthy and balanced life should be easy and accessible to everyone. As a team member well empower you to live this promise each day as you make a truly global impact in your career.
We constantly strive for innovation while transforming and improving the online shopping experience for our customers. We believe that individually we are incredible but when we come together our growth is an industry that is constantly evolving we are on a mission to make an impact on the global market and the individual and collaborative efforts of our people are paramount to helping us succeed.
Whether you work in one of our logistics centers technology hubs corporate offices or even from home your role at iHerb will take you beyond whats expected turning challenge into change. If youre ready for it we want you to join our team. Get started now.
Job Summary:
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. 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.
Job Expectations:
Enforce cGMP compliance across the entire fulfillment lifecyclefrom 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.
The duties and responsibilities described above may provide only a partial description of this position. This is not an exhaustive list of all aspects of the job. Other duties and responsibilities not outlined in this document may be added as necessary or desirable with or without notice.
Knowledge Skills and Abilities:
Required:
- 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
- Six Sigma certification preferred
Equipment Knowledge:
- Experience with Microsoft Office Suite Programs (i.e.: Microsoft Work Excel) and Google Suite.
- Operations equipment
- All software / applications relevant to quality and cGMP
- QMS
- Computer (WMS) system
- GMP / Quality related equipments
Experience Requirements:
7 years in a quality control or GMP-regulated role preferably within a fulfillment manufacturing or distribution environment.
Education Requirements:
Associates degree or equivalent experience required; Bachelors degree in a relevant field preferred or equivalent work experience
Judgment/Reasoning Ability:
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.
Physical Demands:
The physical demands described here are representative of those that must be met by a Team Member to successfully perform the essential functions of this job. While performing the duties of this job the Team Member is regularly required to talk and hear. The Team Member is frequently required to stand walk climb stairs use hands and fingers bend stoop and reach with hands and arms. Reaching above shoulder heights below the waist or lifting as required to store materials throughout the work day. The Team Member may occasionally lift or move materials and products up to 60 pounds. Proper lifting techniques required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment: The noise in the work environment is usually moderate. Other factors are:
Hectic fast-paced with multi-level distractions
Company uniforms closed-toed shoes casual work environment
Warehouse environment may be required to wear safety equipment
Ability to work extended hours as required
Compensation:
The expected salary range for this role is . The actual base pay offered will be determined by factors such as the candidates relevant experience education geographic location and internal equity.If you like wild growth and working with happy enthusiastic over-achievers youll enjoy your career with us!
Staffing Agency Submission Notice
iHerb does not accept unsolicited 3rd party (Agency) candidates. If you are an Agency please send any requests to be considered as a supplier in our Vendor Management System to Do not contact iHerb employees directly. If requested to work on a role any Agency candidates would be presented through the internal recruiting organization.
iHerb is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or veteran status. iHerb provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment.
Required Experience:
Manager
About Company
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