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.What the Job Title Does Each Day:- 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
Our Most Successful Supervisor, Microbiology:- 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
Minimum Requirements for this Role:- 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 Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validation
- Expertise with USP 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
Any of the Following Will Give You an Edge: - Experience Testing in sterile manufacturing location
Benefits of Working at Quva:- 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
- The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
- Range: $74,766 - $102,817 Annually
