Quality Systems Specialist 1st Shift

Quality Systems SpecialistOur 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.This is a full-time role for our 1st shift, working Monday through Friday from 7:00 AM - 4:00PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.What the Quality Systems Specialist Does Each Day:Review and write document change requestsInteract with other departments to address required updates to procedure, forms and/or batch recordsMaintain all quality management systemsGenerate workflows for creation, revisions, review, approval and implementation of procedures, form, batch recordsEnsure documents have the most current and up to date version at all timesReview documents for compliance with company standards for formatting, review, approvals and implementationPerform gap analysis of all quality related procedures to ensure there are no gaps presentMaintain procedures for document workflow, document retention, archiving and retrievalAssist with document retrieval during auditsCoordinate assignment of procedures effective dates with training departmentAct as administrator of controlled documents used for Quality functionsParticipate in process improvements and projects within the companyOur Most Successful Quality Systems Specialists:Understand how to update Standard Operating Procedures, with documentation of summary of changes and version controlAre proficient in Microsoft Office, Adobe, Word, and ExcelHave strong attention to detail and the ability to identify and escalate complex situationsDetail-oriented with strong verbal and written communications skillsMinimum Requirements for this Role:High school diploma or GED from recognized institution or organization requiredAt least 6 months to 1 years' experience at Quva PharmaUnderstanding of archival process, preferred experience in document storage and controls18+ years of ageAble to successfully complete a drug and background checkMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasUnderstanding of archival process, preferred experience in document storage and controlsAny of the Following Will Give You an Edge:1 to 2 years' experience with FDA-regulated operations (cGMP processes)1 to 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facilityBachelor's Degree in life science or related fieldBenefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearOccasional weekend and overtime opportunities with advance noticeNational, industry-leading high growth company with future career advancement opportunitiesAbout Quva: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.Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."