Supervisor, Microbiology

Quva•Bethlehem Township, NJ

11d•$74,766 - $102,817•Onsite

About The Position

Supervise the QC Microbiology laboratory operations. This includes supervision of all daily activities, staff performance, coaching, and developing staff. Support coordination of microbiological analytical activities including release testing, method transfers, and stability studies. Revision and approval of all QC Microbiology Laboratory documents, including Quva’s Laboratory Management System (LMS) samples release. Generation and revision of related QC Microbiology Laboratory procedures and forms. 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 safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

Requirements

BS. or M.S. degree in Microbiology or related field required
5 years prior experience in Quality Assurance / cGMP / FDA regulated industry required
2 year of supervisory or management experience required
Experience and expertise in USP <71> Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validation
Expertise with USP <85> Endotoxin testing, including interpretation of results, investigation, and troubleshooting
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
Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas

Nice To Haves

Experience Testing in sterile manufacturing location

Responsibilities

Mentor, coach, and develop the skills and capabilities of staff
Investigate, and provide thorough scientific justification for all out of specification or atypical test results
Maintain all laboratory activities within compliance to cGMPs, and Quva Quality procedures
Interface with contract laboratories, as a technical expert and business contact
Provide Microbiological expertise and guidance on all relevant scientific and technical issues
Responsible for planning and execution of routine release, stability, and investigational testing for sterility and endotoxins
Review/Approve testing data for Sterility, Endotoxin and Environmental Monitoring, among others
Prepare, and review departmental SOPs and follow policy, procedure and applicable government regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards and safety requirements
Maintain accurate records, in compliance with cGMP and Quva documentation policies
Implement continuous improvement initiatives, to enhance throughput, efficiency, and compliance in the laboratory
Provide scientifically sound investigations of OOS results
Provide Quality and Compliance oversite within the microbiology laboratories
Effectively communicate with, and support Quality and Operations function
Leads, plans, schedules, prioritizes, and manages staff and resources to meet project goals
Makes decisions and sets priorities, schedules work for self and others (when needed), works with minimum direct supervision, and responds to emergency situations
Interacts with management, co-workers and subordinates in a calm, courteous and professional manner

Benefits

Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
17 paid days off, 8 PLP days 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

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