Quality and Compliance Specialist
Legal, Quality Assurance
Manchester, NH, USA
Posted on Thursday, May 11, 2023
Founded in 2011, Fullscript supports 70,000 health practitioners across North America committed to delivering better patient care.
Fullscript provides the ability to prescribe and manage the use of healthcare’s best supplements all in one place. Fullscript's online prescribing platform provides access to over 20,000 practitioner-grade products from over 300 brands, enabling practitioners to create fully personalized plans for their patients. With an unrelenting focus on quality and convenience, Fullscript delivers a patient experience that can't be found anywhere else.
Fullscript is a company where teammates embrace a growth mindset, have their talents celebrated, are given the tools to Grow Faster Than The Company, and are inspired to put their wellness at the forefront of their everyday lives. As a result, Fullscript has been consistently recognized for its culture and leadership. Check out our Culture Guide here.
We’re hiring a Quality and Compliance Specialist to join our QA team.
As a Quality & Compliance Specialist, you will ensure the company adheres to regulatory requirements and industry best practices. You will manage the controlled document process, train employees on cGMP procedures, and organize the Fullscript Quality Program. Additionally, you will manage customer complaints, track documentation, and assist with quality issue organization and maintenance. You will maintain records, evaluate trends, and ensure the confidentiality of supplier data.
Must be located near the Manchester, New Hampshire hub as it is a hybrid role. Monday through Friday day shift with 3 days in the office and 2 days remote.
What you'll do
- Maintain controlled document process and policies for new and revised documents.
- Assist the Quality Manager with assigning and reviewing the documentation received from other departments related to new and revised controlled documents.
- Assist employees in submitting new and revised quality assurance policies and cGMP procedures.
- Train, with the QA/RA Manager, all internal employees on cGMP procedures and maintain training records and documentation as needed.
- Organization of the Fullscript Quality Program, including organization and tracking of documentation, onsite audit scheduling, and follow-up of audit findings.
- Managing all customer complaints: working with Customer Support to receive complaint forms, review, log, and file the forms, as well as notify suppliers of applicable complaints.
- Solicit, organize, and track documentation received from EQP applicants and current partners.
- Assist QA/RA Manager with the organization of Quality partner on-site audits.
- Maintain current and accurate records for all relevant communications, action plans, and effectiveness monitoring.
- Assist QA/RA Manager with organization, maintenance, and tracking of quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
- Maintain Excel tracking logs and assist QA/RA Manager in evaluating trends.
- Perform Quality Assurance functions to accomplish business coordination, monitoring, and reporting of quality performance measures.
- Assist with maintaining records of legal documents and confidential supplier data.
- Other terms and conditions of your employment will continue to apply.
What you bring to the table
- Associate's degree in a related field or equivalent experience.
- At least 3-5 years of experience preferred in quality and compliance roles in the pharmaceutical or related industry.
- Tech-savvy and the ability to pick up new processes, software, and applications quickly.
- Strong knowledge of cGMP regulations and quality management systems.
- Excellent organizational skills and attention to detail.
- Ability to manage multiple tasks and prioritize effectively.
- Strong communication and interpersonal skills.
- Proficiency in Microsoft Office applications, particularly Excel and Google Suite.
- Ability to maintain confidentiality and handle sensitive information.
- Experience with managing customer complaints and quality issues.
- Ability to work independently and as part of a team, with a flexible and collaborative attitude.
- Intrinsically motivated
- Self-starter with the ability to work independently
What we can offer you
- Hybrid role
- Half (Flex) Day Fridays
- Unlimited (Flex) 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)
*Our Wherever You Work Well philosophy means Fullscript teammates get to pick their own office — whether that’s in-office, at home, or a bit of both.
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 taking part in all aspects of the selection process. Please send an email to firstname.lastname@example.org and let us know the nature of your request and your contact information.
Our team handles both personal information and personal health information, which means candidates that receive and accept employment offers must undergo a background check.
Want to learn more? Check us out at www.fullscript.com/careers, find us on social media, or check out our culture guide.
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