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Job Description
Sterility Assurance, Aseptic Process Monitor 2nd Shift QuVa Pharma - 3.5 Sugar Land, TX Job Details Full-time 1 day ago Benefits Paid holidays Health insurance Dental insurance Vision insurance 401(k) matching Opportunities for advancement Qualifications Microsoft Word Cleanroom environmental monitoring Pharmaceutical regulatory compliance Spreadsheets Word embeddings High school diploma or GED Manufacturing facility Pharmaceutical company experience Quality assurance within pharmaceutical industry Quality control within pharmaceutical industry Microbiological testing for sterile processing Sterile medication handling Compounding medications Pharmaceutical manufacturing facility experience Full Job Description Our Sterility Assurance (SA), Aseptic Process Monitor 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 being responsible for gown qualification, EM/PM, media fills, SA investigations, and clean room monitor. The person is the dedicated QA person in the clean room during media fills to ensure good aseptic practices and ensures units are collected, documented, and tested appropriately. The person is responsible for ensuring EM/PM sampling is occurring and incubated. The SA Aseptic Process Monitor also monitors the compounding activities to assess aseptic behavior in the clean room and provide compounder's feedback if concerns are found. 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 2nd shift, working Monday through Friday from 2:00 PM to 6:30 PM. 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
Sterility Assurance, Aseptic Process Monitor Does Each Day:
Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS) Schedule & Proctor Media Fills; Observes technicians in compounding and routine clean room activities Reviews Environmental/Personnel monitoring data to identify any potential trends Providing qualification support for personnel on appropriate gowning techniques, aseptic techniques including execution of Compounder and MQA EM Specialist Competency Assessments as well as qualification support for clean room cleaning. Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units Performs EM/PM sampling as needed; Maintains EM/PM records Maintains Media Fill and Gown Qualification/Requalification records Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations Assists in the generation of Sterility Assurance reports and documents Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) Supports department supervision in oversight and prioritization of day-to-day responsibilities. Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes Evaluation of batches / product for compliance with defined specifications
Our Most Successful Sterility Assurance, Aseptic Process Monitors:
Are accurate and well organized, with strong attention to detail Express energy, show accountability, can multi-task and work in a fast-paced, quality-rich environment Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels Have good interpersonal skills and work effectively and efficiently in a team environment to accomplish goals Have strong verbal and written communications skills Minimum Requirements for this
Role:
A High School diploma or equivalent Able to successfully complete a drug and background check At least 2 years' experience in Quality Assurance, Microbiology, Sterile Compounding in pharmaceutical manufacturing Previous training and experience in environmental monitoring, and sampling Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing Strong Microsoft Word and Excel skills Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas Any of the Following Will Give You an
Edge:
Bachelor's Degree in life science or related field (preferably Microbiology) 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 Occasional weekend and overtime opportunities with advance notice 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) Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
