Sterility Assurance Specialist 2nd Shift

Quva • Sugar Land, TX

15h • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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)

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED