Quality Systems Specialist 1st Shift
About the role
Our Quality Systems Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include maintaining and coordinating Quality Systems related documents for compliance with cGMP and company procedures with minimal supervision. This person will process changes in controlled batch records via Change Control process; issue effective documents including procedures, forms and batch records, and process changes to the procedures. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva’s overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care.
Responsibilities
- Review and write document change requests
- Interact with other departments to address required updates to procedure, forms and/or batch records
- Maintain all quality management systems
- Generate workflows for creation, revisions, review, approval and implementation of procedures, form, batch records
- Ensure documents have the most current and up to date version at all times
- Review documents for compliance with company standards for formatting, review, approvals and implementation
- Perform gap analysis of all quality related procedures to ensure there are no gaps present
- Maintain procedures for document workflow, document retention, archiving and retrieval
- Assist with document retrieval during audits
- Coordinate assignment of procedures effective dates with training department
- Act as administrator of controlled documents used for Quality functions
- Participate in process improvements and projects within the company
Requirements
- High school diploma or GED from recognized institution or organization required
- At least 6 months to 1 years’ experience at Quva Pharma
- Understanding of archival process, preferred experience in document storage and controls
- 18+ years of age
- Able to successfully complete a drug and background check
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas