Supervisor, Sterility Assurance 2nd Shift

Supervisory Duties

• Supervises all environmental and personnel monitoring (EM/PM) staff providing learning and development where appropriate
• Ensures standardization of site Sterility Assurance program with respect to Corporate Policies
• Able to escalate QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Responsible for timely and accurate in process review of EM/PM documents supporting lot release on time
• Provides SME support and review of Deviations / Investigations
• Maintains environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
• Provides training support for personnel on appropriate aseptic techniques and gowning techniques
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining EM/PM records
• Responsible for maintaining all testing equipment in compliance, calibration, and certification
• Assists in developing policies and procedures related to Sterility Assurance
• Enforces applicable personnel policies and procedure

Qualifications

• Bachelor’s Degree in Microbiology, Life Science or another related field
• 2-3 years prior experience in Quality Assurance / cGMP / FDA regulated industry
• 1 year of supervisory or management experience
• Experience training personnel on aseptic techniques and appropriate gowning techniques
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

About Quva

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver 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.”

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