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Quality And Compliance Specialist
Company | Fullscript |
Address | Manchester, NH, United States |
Employment type | FULL_TIME |
Salary | |
Category | Transportation, Logistics, Supply Chain and Storage,Internet Publishing |
Expires | 2023-06-08 |
Posted at | 1 year ago |
Founded in 2011, Fullscript supports 70,000 health practitioners across North America committed to delivering better patient care.
- Maintain controlled document process and policies for new and revised documents
- Perform Quality Assurance functions to accomplish business coordination, monitoring, and reporting of quality performance measures
- Maintain current and accurate records for all relevant communications, action plans, and effectiveness monitoring
- Other terms and conditions of your employment will continue to apply
- Assist QA/RA Manager with the organization of Quality partner on-site audits
- Assist QA/RA Manager with organization, maintenance, and tracking of quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
- Assist the Quality Manager with assigning and reviewing the documentation received from other departments related to new and revised controlled documents
- Solicit, organize, and track documentation received from EQP applicants and current partners
- Assist with maintaining records of legal documents and confidential supplier data
- 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
- Organization of the Fullscript Quality Program, including organization and tracking of documentation, onsite audit scheduling, and follow-up of audit findings
- Assist employees in submitting new and revised quality assurance policies and cGMP procedures
- Maintain Excel tracking logs and assist QA/RA Manager in evaluating trends
- Train, with the QA/RA Manager, all internal employees on cGMP procedures and maintain training records and documentation as needed
- Tech-savvy and the ability to pick up new processes, software, and applications quickly
- Associate's degree in a related field or equivalent experience
- Excellent organizational skills and attention to detail
- Strong communication and interpersonal skills
- Proficiency in Microsoft Office applications, particularly Excel and Google Suite
- Self-starter with the ability to work independently
- 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
- At least 3-5 years of experience preferred in quality and compliance roles in the pharmaceutical or related industry
- Ability to manage multiple tasks and prioritize effectively
- Experience with managing customer complaints and quality issues
- Strong knowledge of cGMP regulations and quality management systems
- Ability to maintain confidentiality and handle sensitive information
- Intrinsically motivated
- Ability to work independently and as part of a team, with a flexible and collaborative attitude
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