Quality Assurance Specialist jobs in Lancaster, PA

Fullscript is the leading platform for prescribing integrative health products and simplifying the path to lifelong wellness. We are the trusted care delivery platform for practitioners who want to create partnerships with their patients and want a simpler way to deliver integrative plans. We are changing the way health is prescribed and making a positive impact on the lives of millions through our work.

Experience what it’s like to work for a mission-driven company committed to helping people get better.

We’re hiring a Quality Assurance Specialist to join our QA team.

Role Overview

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, and document control, and activities in support of 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.

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 is responsible for ensuring enforcement of our cGMP practices on site and will report to the QA Safety & Facilities Manager any concerns or opportunities for improvement.

• Provides cGMP and controlled document training for new hires and refresher training annually for all warehouse Departments and maintains training records. Assists employees in submitting quality assurance policies and cGMP procedures.

• Assists departments with coordinating audit information and recommends 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.

• Assists the Senior Manager of Quality with the organization of quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.

• Maintains current and accurate records of all relevant communications, audits, corrective action plans, preventative maintenance, and effectiveness monitoring.

• To perform other assigned duties as necessary within the realm of the Quality department.

• Work independently 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 use of Microsoft programs (Word, Excel, PowerPoint)

• Familiar with cGMP standards and/or ISO certification in same or related industry.

• Experience with and Inventory ERP system is a plus

• Associates degree required; Bachelor’s degree preferred.

• 2-3 plus years of related quality coordination experience in same or related regulated industry.

• Ability to work independently within the warehouse environment

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 meeting Wednesday)

• Weekly team-building activities /Bi-Monthly team meetings

Life At Fullscript

Helping people get better is core to everything we do. That said, our purpose extends well beyond our platform. We are building an organization where people thrive, grow, and have a high impact through their work.

The important stuff

Our team handles a lot of sensitive health information, which means we require all candidates who receive and accept employment offers to complete a background check before being hired.

Fullscript is committed to diversity in its workforce and is proud to be an equal-opportunity employer. We are excited to work with talented people, period. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national or ethnic origin, gender, age, disability, sexual orientation, gender identity and/or expression, marital or civil status, political affiliation, family or parental status, or any other status protected by the laws or regulations in the jurisdictions in which we operate.

Accommodations are available on request for candidates participating in all aspects of the selection process. Please email accommodations@fullscript.com and let us know the nature of your request and your contact information.

Want to learn more? Check us out at www.fullscript.com or find us on social media.