Quality Operations Specialist

What you'll do

• Sanitation / Hygiene / Housekeeping:
• Maintain sanitation, hygiene, and housekeeping program of the distribution center to meet cGMP and regulatory requirements.
• Perform regular DC inspections and follow-up actions to correct and prevent non-conforming issues, and escalating concerns to the Quality Operations Manager as needed.
• Ensure that sanitation, hygiene, and housekeeping procedures and records are adequate and suitably maintained.  
• Temperature / Humidity Controls:
• Ensure that temperature / RH controls of the distribution center meet cGMP and regulatory requirements and that temperature / RH procedures and records are adequate and suitably maintained.  
• Pest Controls:
• Coordinate pest control activities for the distribution center to ensure compliance with cGMP and regulatory requirements. 
• Maintain pest control procedures and records.
• Product Returns & Disposition:
• Oversee product returns and product disposition decisions at the distribution center(s) to ensure compliance with established requirements and timely and effective handling.  
• Ensure that product returns & disposition procedures are records are adequate and suitably maintained.
• Environmental Controls:
• Ensure that environmental controls of the distribution center meet cGMP and regulatory requirements. 
• Maintain environmental control procedures and records.
• Preventive Maintenance & Calibration:
• Oversee the preventive maintenance and calibration program to ensure that all critical equipment that may affect the quality and safety of the product is suitably maintained to meet established requirements. 
• Maintain preventive maintenance procedures and records.  
• Training:
• Provide cGMP and cGDP training for new hires and refresher training annually for all distribution center employees, and ensure completion of training records. 
• Assist employees with understanding quality assurance policies and cGMP procedures.
• External Audits:
• Support external quality / regulatory audits.  
• Working closely with distribution center management and quality management to ensure site readiness, coordinate documentation / record availability, and ensure a suitable facility environment to support successful audits.
• Internal Audits:
• Perform internal quality audits and / or product verification audits as per internal audit procedure requirements. 
• Complete internal audit reports and follow-up on non-conforming issues to drive correction and prevention of issues and escalate concerns to the Quality Operations Manager as needed.
• General:
• Support product recalls, product quarantine directives, and customer complaint activities as needed. 
• Support system verification and validation activities as needed.
• Additional quality-related duties may be assigned as needed.

Who you are

• +5 years of quality experience within a regulated industry, e.g., food, dietary supplement, drug, or medical device industries.
• A thorough understanding of cGMP requirements.
• Meticulous attention to detail, superior organizational capabilities, and a keen investigative approach are crucial.
• Proactive self-starter with the ability to concentrate and drive tasks to completion autonomously.
• Exceptional verbal and written communication skills are required for effective dissemination of information and collaboration. with colleagues across all organizational levels, as well as potential interactions with regulatory agencies.
• Proficiency in Microsoft Office applications and /or Google Suites, including Word, Excel, and PowerPoint.
• Familiarity with WMS / ERP systems will be preferred.
• Ability to work independently within a warehouse environment.

What we can offer you

• Flexible Paid Time Off 
• Sick time
• Fullscript’s 401k with matching
• Stock Options
• Flexible benefits package (medical, dental, vision) with HSA
• Discount on Fullscripts catalog of products for family & friends
• Company paid holidays
• Wellness programs and initiatives
• Paid parental leave
• Climate controlled warehouse