Sterility Assurance Specialist 2nd Shift at Quva

Sugar Land, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

0.0

Posted On

13 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sterility Assurance, Environmental Monitoring, Personnel Monitoring, Aseptic Technique, cGMP Compliance, Quality Assurance, SOP Adherence, Media Fill Proctoring, Microsoft Word, Microsoft Excel, Sterile Compounding, FDA Regulations, Deviation Investigation, Gowning Techniques, Batch Evaluation, Technical Writing

Industry

Pharmaceutical Manufacturing

Description

Our Sterility Assurance 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 the oversight and performance of the Quality Assurance aspects of Sterility Assurance, including Environmental/Personnel Monitoring teams to ensure compliance within the facility. 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 second shift, working Monday through Friday from 2:00 PM to 10:30 PM This is a set, consistent schedule 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 Sterility Assurance Specialist Does Each Day: * Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS) * Schedule & Proctor Media Fills * Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units * Performs EM/PM sampling; Maintains EM/PM records * Periodically reviews Environmental/Personnel monitoring data to identify any potential trends * Providing training support for personnel on appropriate aseptic techniques and gowning techniques including execution of Compounder Competency Assessments * Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations * Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) * Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes * Provides an established technical expertise for current processes and oversees training of department personnel on new processes * Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products * Evaluation of batches / product for compliance with defined specifications * Sampling, inspection, and control of commercial product labels * Review and approval of shipping documentation for commercial products Our Most Successful Sterility Assurance Specialists: * Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility * Are detail-oriented with strong verbal and written communications skills * Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards * Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions * Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment * Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback Minimum Requirements for this Role: * A High School diploma or equivalent * Able to successfully complete a drug and background check * Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation * 18+ years of age * Strong Microsoft Word and Excel skills * Knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product * 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 Any of the Following Will Give You an Edge: * Bachelor’s Degree in life science or related field * At least 1 year experience at Quva Pharma * At least 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility * At least 2 years’ experience with FDA-regulated operations (cGMP processes) Benefits of Working at Quva: * Set, full-time, consistent work schedule * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * 17 paid days off plus 8 paid holidays per year * National, industry-leading high growth company with future career advancement opportunities About 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.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees [https://onequva.com/california-applicant-employee-privacy-notice-quva]

Responsibilities

Oversee and perform Quality Assurance aspects of Sterility Assurance, including environmental and personnel monitoring to ensure facility compliance. Responsibilities include proctoring media fills, reviewing manufacturing data, and supporting sterility investigations to maintain safety and efficacy standards.