Job Description

Job Description

Job Description

Salary:

Quality Assurance Specialist – CMO Testing

Elemental Enzymes is seeking a highly motivated and detail-oriented applicant to join our Manufacturing team as a Quality Assurance Specialist – Contract Manufacturing and Testing reporting to the Quality Assurance (QA) Manager. The Quality Assurance Specialist will provide Quality oversite to ensure compliance with applicable quality objectives and regulatory requirements, with a focus on providing QA oversight to Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) activities. The QA specialist will have responsibilities in the following areas:

Product & Process Responsibilities

• Provide quality oversight for external manufacturing/testing activities, acting as the primary quality point of contact. This includes approval of technical transfer of manufacturing operations and analytical test methods.

• Manage CMO and CRO supplier qualifications and agreements, including performing onsite audits as determined by the Quality Risk Management (QRM) process. Perform periodic reviews of supplier history, trends, and investigations to determine the need for requalification.
• Track and oversee Supplier Corrective Action Reports (SCARs). Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
• Oversee product and process change management ensuring product quality is not impacted with any product/process proposed changes.
• Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelines.
• Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any trends, deviations, and investigation reports related to lot release of product disposition ensuring the compliance of the whole product specifications.

• Perform Product Disposition and Lot Closure using enterprise resource planning (ERP) programs.
• Track and respond to quality-related customer questions and/or complaints.
• Ensure process control measures are in place and followed in product manufacturing.
• 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.
• Support other QA activities as assigned.
• Support Lean Manufacturing principles to ensure process-in-control.

Quality Systems Responsibilities

• Lead the development of the QA supplier management program.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
• Interact with key stakeholders such as R&D, Process Development, Manufacturing, Regulatory Affairs, and Commercial to ensure that products are manufactured in accordance with established procedures and appropriate regulations.
• Lead and participate in internal/external inspection and audits.
• Maintain metrics related to quality supplier management in support of the Management Review.
• Generate and report data for management.

Knowledge, Experience, and Skills

• Expert knowledge of Quality Systems. Working knowledge of ISO 9001 Quality Management Systems is strongly preferred.

• Good working knowledge of Environmental and Occupational Health and Safety systems. Knowledge of ISO 14001/45001 EHS and OHS Systems is preferred.

• Good working knowledge of Good Manufacturing Practices, (e.g. 21 CFR 211, 21 CFR 820) standards applicable to biotechnology. Prior experience in pharmaceutical and regulated bio-tech industry is strongly preferred.
• Great experience in performing and leading audits.
• A working knowledge of ERP Systems, e.g., NetSuite is advantageous.
• Basic knowledge of six sigma, LEAN, and/or Structured problem-solving method root cause analysis tools used for identifying and correcting deviations.

Basic Qualifications/Requirements

• Bachelor’s degree in the biological sciences, biological/chemical engineering or related field and 7 years of progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience

• Must be able to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors.
• Must be able to effectively participate in cross-functional teams.
• Must be able to coordinate the planning, organization, and implementation of project deliverables within specified objectives.

• Must be an accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures.

• Must possess an excellent attitude with strong verbal, written, and interpersonal communication skills. Must have strong analytical skills.

• Must be a self-starter, able to work independently, with minimal supervision. Needs to be comfortable working in a fast-paced small company environment.

• Must be able to interpret and apply procedural and regulatory guidance, with an understanding of risk, and provide phase-appropriate appropriate decisions.
• Ability to adjust workload based upon rapidly changing priorities.
• Role is onsite with potential flex schedule depending on the candidate. Ability to travel (up to 10%) domestic and international required.

Physical Requirements

• Reaching: Extending hand(s) and arm(s) in any direction.
• Standing: Particularly for sustained periods of time.
• Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position.
• Must be able to lift up to 50 lb. occasionally. Must be able to wear required PPE, including respirators. 
• 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.
• 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.

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To apply, please complete the job application on our website and submit your resume and cover letter.

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