A Quality Assurance Specialist ensures that Fullscript’s products and services are of the highest quality. The Quality Assurance Specialist will assist the Compliance Manager & QA Safety & Facilities Manager with document organization, document control, and activities supporting Fullscript’s cGMP practices.
The Quality Assurance Specialist will assist with Customer complaint activities, including tracking, review and logging, and supplier notifications. The Quality Assurance Specialist will assist with training records and responsibilities, including cGMP training. The Quality Assurance Specialist will report to the QA Safety & Facilities Manager.
Shift: Monday - Friday
Hours: 9 am to 5 pm
Location: Lancaster, PA - onsite only - not a hybrid role
What you'll do
- Track Fullscript controlled documents and maintain training records; may also assist in maintaining records of legal documents and confidential supplier data.
- Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site.
- Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager.
- Provide cGMP and controlled document training for new hires and refresher training annually for all warehouse departments and maintain training records.
- Assist employees in submitting quality assurance policies and cGMP procedures.
- Assist departments with coordinating audit information and recommend appropriate data-gathering mechanisms, procedures, etc.
- Is familiar with cGMP standards and/or ISO certification in the same or related industry.
- Document control expert for revision control, processing, and filing (hard copy and electronic).
- Maintain Excel tracking logs and create matrix and reports to assist the Compliance Manager in evaluating trends.
- Work with the Returns team on any customer complaint returns or undeliverable packages.
- Perform daily and monthly DC audits/inspections and ensure any corrective actions from audits are closed.
- Responsible for knowing current QA regulations pertinent to the dietary supplement industry and training and enforcing regulations within the distribution center.
- Perform internal audits at the distribution center as required and ensure preparedness for regulatory on-site audits.
- Assist the Senior Manager of Quality with managing quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
- Maintain current and accurate records of all relevant communications, audits, corrective action plans, preventative maintenance, and effectiveness monitoring.
- Perform other assigned duties as necessary within the realm of the Quality department.
- Work independently in an on-site (not a hybrid/remote) role.
What you bring to the table
- Detail-oriented, organizational, and investigative qualities essential
- Focused and self-starter mentality.
- Excellent verbal and written communication skills
- Interpersonal skills for successful interaction with company employees at all levels and possibly regulatory authorities
- Expertise in using Microsoft programs (Word, Excel, PowerPoint).
- Familiar with cGMP standards and/or ISO certification in the same or related industry.
- Experience with an Inventory ERP system is a plus.
- Associate degree required; Bachelor’s degree preferred.
- 2-3 plus years of related quality coordination experience in the same or related regulated industry.
- Ability to work independently within the warehouse environment.
- Comfortable dealing with upper management, auditors, etc.
What we can offer you
- Flexible PTO
- Fullscript’s 401k
- Stock Options
- Flexible benefits package (medical, dental, vision) with HSA
- Discount on Fullscript catalog of products for family & friends
- Training budget and company-wide learning initiatives
- Employee Wellness Programs (including no meetings on Wednesdays)
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