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 10:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ 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
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 Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.
As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.
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."
