Quality Engineer

Company Overview:

Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions and vaccines. Phibro’s revenues are more than $750 million and are supported by over 1400 employees worldwide.

Phibro-Tech, Inc. is part of Phibro Animal Health’s Performance Products division, located in Santa Fe Springs, California. Since 1984 Phibro-Tech has served the electronic, semiconductor and water treatment industries by taking in their used materials, recycling them, and using those materials to manufacture new copper and iron-based products. Phibro-Tech helps all Californians stay safe, healthy, and sustainable.

Roll up Regeneration is the fastest growing business sector within Phibro-Tech and it focuses on an innovative method of treating CA drinking water of Hexavalent Chromium. Hexavalent Chromium has been reported to cause cancer and the state of CA has lowered the allowable Chrome 6 levels in potable water to benefit over 5.5 million residents. Hundreds of water wells across the state are affected by this Chrome 6 problem and Roll up Regeneration is leading the way to deliver a practical and cost-effective solution. Join the team to tackle this worthy challenge and become a part of such a rewarding solution to our state’s problem.

Position Overview:

We are seeking a highly detail-oriented, organized Quality Engineer to join our team and specialize in technical documentation. This individual will be responsible for creating, maintaining, and ensuring the accuracy and integrity of documentation within the Rollup Regen (RUR) Business sector of the company. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, a passion for ensuring that documentation processes comply with internal standards and industry regulations. Critical thinking and problem-solving aptitude related to drinking water treatment and testing methods is favorable.

Position Details

This role is primarily responsible for managing the cGMP programs in the areas of qualification, stability testing, validation, compliance, audits, in support of lab and production quality requirements. Specific responsibilities include but are not limited to:

Key Responsibilities

• Review and approve batch records, quality documents including process master documentation, product specifications, change control documents, qualification documents, validation documents, and process related documents
• Review and authorize orders re-working and processing
• Authorize Certificate of Analysis and release products upon completion
• Author and revise SOPs and quality reports
• Evaluate and approve equipment cleaning, equipment qualification protocols and reports, process validation protocols and reports
• Manage stability program including approval of stability data report
• Assist in client and FDA audits and inspections
• Conduct internal audit and inspections to ensure cGMP compliance

Key Competencies

Communicating EffectivelyPrioritizing and Organizing WorkDrivenAccountableCollaborativeDelivering High Quality WorkManaging TimeSupporting Organizational GoalsThinking GloballyUsing Computers and Technology

Skills

Able to develop detailed communications documents that are readily understood by co-workers, vendors and clients.Able to develop and maintain detailed records.Extremely high level of attention to detail and high standard of quality.Demonstrated resourcefulness and initiative

Education & Experience

• Bachelor's Degree in a relevant field
• Experience in pharmaceutical environments highly preferred

Physical Requirements

Required to sit frequentlyRequired to stand frequentlyRequired to talk or hear constantly

Key Responsibilities:

• Write technical documents related to RUR business, including risk assessments, method statements, standard procedures, specifications, reports, and work instructions.
• Oversee the review and approval process for quality documentation to ensure compliance with company policies, industry standards, and regulatory requirements.
• Interact with external partners, customers, and authorities in a professional and effective manner to drive the business forward.
• Ensure proper version control for all documentation, tracking changes, approvals, and revisions in line with organizational and regulatory guidelines.
• Assist in internal and external audits by ensuring that all documentation is up-to-date, complete, and easily accessible for review.
• Provide guidance and training to team members on document control practices, procedures, an