Overview
Senior Quality Engineer Jobs in Irvine, CA at Precision Castparts Corp.
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 2nd 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.”
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 notice from the Department of Labor.
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Title: Senior Quality Engineer
Company: Precision Castparts Corp.
Location: Irvine, CA
