Quality Control Analyst Team Lead

Quality Control Analyst Team Lead

Responsibilities:

• Lead QC team in the laboratory for routine questions and direction with support and direction of QC Manager
• Oversee and schedule analytical tests, enzyme quantification assays, and microbiological tests
• Lead in the process and implementation of QA/QC methods, protocols, and systems
• Lead instrumentation requirements and documentation according to QA/QC program development
• Lead writing, evaluation, and updating of Standard Operating Procedures
• Oversee and schedule routine and longevity testing of incoming raw materials, in-process, and finished goods
• Define new analytical testing method development following Business Case approval and direction from QC Manager
• Lead enzymatic and microbiological assay improvements and troubleshooting with support from QC Manager
• Lead training program development by documenting assay proficiency requirements and train new analysts in assays
• Lead daily GEMBA and LEAN methods for efficiency improvements in the laboratory with direction from QC Manager
• Lead data analysis of QC assay results and documentation
• Assess yield, activity, and purity throughout manufacturing processes
• Ensure compliance with manufacturing standards and product specifications
• Work with R&D, Process Development, and Operations departments to assist in product support and performance inquiries, both internal and external
• Report and work directly with QC Manager in COGs and KPI requirements for laboratory
• Support regulatory requirements and understanding of global impacts and varying country specifications
• Take initiative to reduce process variation and product nonconformities
• Maintain accurate and thorough batch records, document experiments, results, and conclusions
• Take part in the batch manufacturing of products when demand requires
• Analyze raw material, in-process, and final product performance. Identify non-conformance and areas of improvement.
• Coordinate cross-functionally to maintain a safe and efficient workplace throughout all of EE’s procedures
• Effectively communicate results to supervisor and present work to the Manufacturing Team
• Stay up to date with relevant industry regulations and standards as well as new technologies.

Minimum Requirements of Role:

• Bachelor's degree; Master’s or Ph. D preferred in Biology, Chemistry, Biochemistry or Microbiology
• Extensive experience working in a Quality Control / production experience in a cGMP facility preferred.

• Ability to understand technical process knowledge within area of responsibility.
• Ability to work independently and with others to accomplish goals and priorities.
• Ability to Lead QC Team in daily Lab Tasks
• Ability to work directly with QC Manager for alignment on all laboratory requirements
• Flexibility and teamwork skills.
• High level of energy and regular, consistent attendance.
• Ability to work between multiple locations and remotely with high levels of performance
• Excellent oral and written communication skills

Physical Requirements of Role:

• Reaching: Extending hand(s) and arm(s) in any direction.
• Standing: Particularly for sustained periods of time.
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. This factor is important if it occurs to a considerable degree and requires substantial use of upper extremities and back muscles.
• Feeling: Perceiving attributes of objects, such as size, shape, temperature or texture by touching with skin, particularly that of fingertips.
• Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.
• Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or finger, picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
• Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.
• Those with this position must be able to work in Biosafety Level 2 Laboratory which can cause more illnesses to those with immunocompromised systems.

Job Location: St. Louis, MO, United States
Position Type: Full-Time/Regular/Salary/Exempt
Salary: Competitive base range
Benefits: 401K, Healthcare, Dental, Vision, Life Insurance, HSA/FSA Options, Employee Assistance Program, Short-Term Disability, Long-Term Disability, Pet Insurance, Accident Insurance, and Dependent Care Account

About Elemental Enzymes
Elemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and protein inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people – like you and me. Success is a byproduct of responsible production. That’s why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.

Apply
Please fill out the application and attach a cover letter and CV/Résumé. References required upon request.

Job Type: Full-time