Quality Assurance Associate

Quality Assurance (QA) Associate

Elemental Enzymes is seeking a highly motivated and detail-oriented applicant to join our Manufacturing team as a Quality Assurance (QA) Associate reporting to the Quality Assurance (QA) Manager.  The Quality Assurance Associate will perform the daily activities associated with administering the Quality system.  The QA Associate will have responsibilities in the following areas:

Product & Process Responsibilities:

• Issuance of approved protocols including, but not limited to, Manufacturing Batch Record, Equipment Qualifications, and Training Protocols.
• Administration of the electronic Quality Management System (QMS)
• Management of controlled document lifecycles.
• Maintenance of established Key Performance Indicators (KPIs)
• Review of executed batch records, analytical data, and associated documentation, including any trends, deviations, and investigation reports related to lot release or product disposition.

• Performing Product Disposition and Lot Closure within the Quality system and Enterprise Resource Planning (ERP) systems.
• Ensure process control measures are in place and followed during the manufacturing process.
• Identifies critical, non-critical, user calibrated, and non-calibrated instruments per the process requirements (in conjunction with process development) and manages the calibration of the instrument to ensure compliance.
• Works with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Identify process change management opportunities ensuring product quality is not impacted with any product/process proposed changes.
• Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelines.
• Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
• Manage and monitor CAPAs for successful completion and successful implementation
• Monitor all proposed changes of CAPAs through the Management of Change (MOC) process.
• As assigned, provide QA oversight for other processes, including training.
• Support Lean Manufacturing principles to ensure process-in-control.

Quality Systems Responsibilities:

• Write, review, and approve Operating Procedures, Manufacturing documents, and other controlled documents under a Quality Managed System (QMS).
• Maintains routine programs and processes to ensure high quality products and compliance with current best practices, such as cGMP, and with ISO9001 management requirements.
• Participate in and learn to lead internal/external inspection and audits.
• Generate and report data for management.

Knowledge, Experience, and Skills:

• Good working knowledge of Good Manufacturing Practices standards applicable to biotechnology is preferred
• Quality experience as a Quality Assurance team member or a participant who has been responsible for maintaining Quality documentation and activities.
• Ability to effectively participate in cross-functional teams.

• An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
• Excellent attitude with strong verbal, written, and interpersonal communication skills
• Self-starter, able to work independently.
• Process based mindset and the ability to recognize opportunities for improvement.

Basic Qualifications/Requirements:

• Previous experience working within the structure of a Quality Management System
• Prior experience in pharmaceutical and/or regulated bio-tech industry is preferred.
• Demonstrates basic knowledge Quality System components.
• Ability to understand risk-based decision making.
• Ability to effectively negotiate and build collaboration amongst individuals
• Good interpersonal skills
• Strong written communication skills
• Strong analytical skills
• Comfortable in a fast-paced small company environment and operate with minimal direction
• Ability to adjust workload based upon rapidly changing priorities

Physical Demands:

• Extending: Extend self in a direction to complete a task.
• Stationary Position: Remaining in one position for sustained periods of time.
• Moving:  Moving to accomplish tasks, particularly for long distances or moving from one work site to another.
• Fine Motor Skills: Using fingers for tasks such as typing, picking, or pinching, rather than full hand movements.
• Transporting: Moving objects from a lower to a higher position or moving objects horizontally from position-to-position. Objects can be up to 45 pounds in weight.
• Manual Handling: Gripping, grasping, or applying pressure to objects using fingers and palms.
• Operating: Using tools and equipment including a work computer and other office devices such as printers, calculators, etc.
• Repetitive motion: Engaging in recurring movements of the wrists, hands, or fingers, such as typing, assembling components or pipetting.
• Medium Work: Exerting up to 50 pounds of force occasionally, up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
• Personal Protective Equipment (PPE): The worker is required to wear appropriate PPE as necessary for their role, including but not limited to gloves, safety eyewear, lab coats, hearing protections, and/or respiratory protection depending on the work environment and exposure risks.

 Physical Requirements:

• Sensory Touch: Assessing the size, shape, texture, or temperature of objects by touch, particularly with fingertips.
• Communicating: Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and accurately. Perceiving sound details at normal speaking levels. Alternative methods of communication can be utilized as necessary.

Environmental Exposure:

• Those with this position must be able to work in Biosafety Level 2 Laboratory where there may be exposure to biological agents. Individuals with immunocompromised systems may be at increased risk in these environments.

Job Location: St. Louis, MO, United States

Position Type: Hourly/Non-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.