Manager, Quality Control Microbiology
Manager, Quality Control Microbiology
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1 Vacancy
Job Description
About This Role
Our Manager QC Microbiology plays a vital role within our organization. Once you complete our training your responsibilities will include managing all the Quality Control Microbiology Labs supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position will also operate within the legal and regulatory compliance producing a quality product. Additional responsibilities include managing the Microbiology staff coordinating roles responsibilities and projects. 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.
Scope:
- Responsible for Microbiological testing and release of commercial/marketed products
- Responsible for the transfer of microbiological methods from R&D and between sites
- 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
- Manage and report on departmental Key Performance Indicators (KPI)
- Provide Microbiological expertise and guidance on all relevant scientific and technical issues
Responsibilities may include:
- Responsible for planning and execution of routine release stability and investigational testing for sterility and endotoxins
- Prepare review and approve departmental SOPs
- Maintain accurate records in compliance with cGMP and QuVa documentation policies
- Implement continuous improvement initiatives including new instrumentation or methods 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 functions
- Manage laboratory budgets
- Responsible for implementation and maintenance of the laboratory safety program
- Other duties as assigned
Qualifications:
- Legally authorized to work in the job posting country
- B.S. or M.S. degree in Microbiology or related field required
- 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
- 3 years of supervisory or management experience required
- Experience in sterile manufacturing preferred
- 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
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
- 22 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
- 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: $117000 - $136000 Annually
- This role is also eligible for an annual incentive bonus subject to program terms and guidelines
About Quva:
Quva provides industry-leading health-system pharmacy services and solutions including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners with health systems to aggregate normalize and analyze large amounts of complex data across their sites of care and through proprietary machine learning transforms data into actionable insights supporting revenue optimization script capture inventory management drug shortage control and more. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.
Required Experience:
Manager
Employment Type
Full-Time
