Sterility Assurance Specialist 3rd Shift

Responsibilities

• Oversight and performance of the Quality Assurance aspects of Sterility Assurance, including Environmental/Personnel Monitoring teams
• Schedule & proctor media fills
• Perform reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
• Perform EM/PM sampling; Maintain EM/PM records
• Periodically review Environmental/Personnel monitoring data to identify any potential trends
• Provide training support for personnel on appropriate aseptic techniques and gowning techniques including execution of Compounder Competency Assessments
• Support for sterility investigations including EM/PM excursions and review of deviations and investigations
• Work in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
• Demonstrate a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Established technical expertise for current processes and oversee training of department personnel on new processes
• 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

Qualifications

• 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

• 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 turn 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.