Our Microbiologist III 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 providing and performing analysis, scientific guidance and interpretation of microbiology and environmental monitoring testing results to management. This person performs data review and approvals, works, and performs daily sample testing schedules and timelines to deliver sterility/endotoxin test results in a timely manner for overall product release. 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 1st shift, working Monday through Friday. This is a set, consistent schedule 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 Microbiologist III Does Each Day:

• Act as a mentor providing direction and guidance to support the QC Microbiology Lab Supervisor/Manager
• Performs, compiles, and interprets tests data results of environmental monitoring, sterility, endotoxin, growth promotion testing of media and microorganisms’ identification
• Performs data review and approvals of environmental monitoring, sterility, and endotoxin test results
• Performs daily testing schedules and makes sure they are followed and completed
• Assists the QC Microbiology Lab Supervisor/Manager in conducting investigations of all non-conforming results
• Identifies environmental microbial isolates by classical techniques and automated identification methods to meet the requirements of the microbial environmental monitoring program
• Evaluates cleaning effectiveness on a routine basis to determine robustness of disinfection
• Develops and/or performs water sampling, including DI water, WFI and steam per the program (when needed)
• Performs and/or oversees surface, air sampling and equipment monitoring per the EM program
• Performs and/or oversees environmental personnel monitoring in compliance with gowning requirements
• Validates methods for Scan RDI sterility test, traditional USP <71> sterility test, and endotoxin (USP <85>) testing for finished goods, intermediates, and raw materials
• Generates performance qualifications reports after testing methods validations
• Prepares trend reports for the environmental monitoring program per facility standards and communicate results
• Trains and maintains current training status on required equipment and procedures
• Maintains current status on required equipment procedures and calibrations
• Creates, develops and/or revises Standard Operating Procedures (SOPs), Facilities Work Orders (WO), among other company related documents

Our Most Successful Microbiologists III:

• Plans, schedules, prioritizes, and manages time to meet project goals of regulatory compliance and facility requirements
• Makes decisions, set priorities and schedule work for self. Work with minimum direct supervision, and respond to emergency situations
• Interacts with management and co-workers in a calm, courteous and professional manner
• Observes and constructively trains and corrects laboratory and production staff, as well as collaborate with management to resolve issues in a timely manner
• Has strong Microsoft Word and Excel skills

Minimum Requirements for this Role:

• Bachelor’s Degree
• Minimum 4-6 years of experience in QC Microbiology required, preferably in pharmaceutical manufacturing
• In-depth knowledge and experience in environmental monitoring, sampling, laboratory microbiology Sterility testing (USP 71), Endotoxin Testing, Growth Promotion Testing and Methods Validation
• Thorough understanding of FDA and 21CFR Part 211 cGMP requirements and guidelines for sterile drug products with emphasis on Sterile Drug Products produced by Aseptic Processing
• 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:

• Degree with a discipline in Microbiology
• Experience with Rapid Microbiological testing methods a plus, like ScanRDI Sterility Testing methodology and Endonext/Endosafe

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 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.”