Supervisor, Microbiology
About the role
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.
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
- Plan, schedule, prioritize, and manage staff and resources to meet project goals
- Make decisions and set priorities, schedule work for self and others (when needed), respond to emergency situations
- Communicate effectively with, and support Quality and Operations function
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 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
Qualifications
- Currently authorized to work in the United States on a full-time basis
Skills
- Attention to detail
- Precision
- Commitment to quality
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
Pay
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.
Raise: $74,766 - $102,817 Annually
Schedule
At will