Specialist III, Quality Assurance

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.

Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.

The Role:

We are looking for our next Analyst III, Quality within our Quality Department. This position performs the chemical/physical analytical evaluation of raw material, intermediate, process, and finished products to ensure product meets customer specification and consumer safety standards. Makes risk analysis and usage decision of non-conformances. Generates test result documentation. Provides technical assistance for internal and external customers and when non-conformances are detected, determines root cause, preventive and corrective actions. Develops people on the team. The role may require working a 12-hour rotating shift to support QC for plant production.

This position is located at Newark, DE

Compensation:

The current salary range for this role is estimated to be $67,000 - $97,000. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location.

What We Offer:

• A highly collaborative team environment with ample room for exponential career growth.
• Competitive pay, annual performance bonus, comprehensive benefits, 6.2% company retirement contribution, and professional development opportunities.
• Generous paid time off and 12 annual paid company holidays.
• 12 weeks 100% paid maternity leave, and up to 4 weeks 100% paid parental leave (including adoption/surrogacy/foster care leave) for non-birthing parents.
• Student loan repayment assistance and tuition reimbursement program for select roles.
• Annual wellness benefit and wellness centered programs focused on your health needs.

What You'll Do:

Technical/Functional

• Perform testing associated with the QC chemistry lab;
• Provide support to operations regarding test results and impact on production;
• Conduct calibrations and maintain records for the lab calibration program;
• Provide general lab support by maintaining samples and consumable supplies and follow up on maintenance work orders;
• Perform instrument troubleshooting;
• Investigate and make recommendations with respect to plant investigations;
• May require support for QC Microbiology lab and perform functions of the Microbiologist as necessary;
• Participate in the training of new analysts. Provide training support for entry level analysts as necessary;

Quality

• Follow all standard lab procedures and testing methods;
• Comply with cGMP, ISO 9000, and FSSC 22000 standards, both in the laboratory and in the plant;
• Maintain accurate records of all test results and report them in a timely manner in alignment with the quality system;
• Ensure documentation and records are maintained according to plant procedures and the quality system;
• Suggest changes to procedures and methods as needed.

Safety/Health/Environment

• Conduct all lab and process development procedures in a manner that protects the safety & health of self & other individuals;
• Wear appropriate Personal Protective Equipment (PPE);
• Assist in maintaining at a high level all laboratory and process development safety equipment and cleanliness/housekeeping standards;
• Ensure all work is conducted with respect to safety precautions, equipment safety devices;
• Ensure disposal of all laboratory wastes are in compliance with regulatory and plant guidelines.
• Ensure all operations are carried out in accordance with EHS policies and practices.
• Ensure Standard Operating Procedures are followed for all tasks
• Support site safety programs, behavioral based safety activities, audits and other EHS activities to improve safety performance.
• Report and take necessary action to resolve unsafe conditions immediately
• Comply with external and internal requirements and regulations (IFF, OSHA, DNREC, etc).
• Conduct all work in compliance with systems for maintaining a safe workplace (Management of Change, Environmental Management System, PSM etc.);

Communication

• Proactively communicate issues and ideas for improvement;
• Ensure all key stakeholders in your areas of responsibility have required information in a timely manner;
• Effectively utilize all communication systems (telephone, voicemail, electronic mail, memos, posting) to stay informed and inform others as appropriate;
• Provide and/or respond to information requests in a timely and complete manner;
• Demonstrate an attitude of respect and professional interaction with others.

Personal Development/Learning

• Actively pursue opportunities for continuous learning and expanded capability development;
• Develop cross functional capabilities in the chemistry lab and micro lab.

Administration/Financial

• Ensure cost conscientious is a major consideration in utilization of laboratory materials and equipment;

What You'll Need:

Education:

• Minimum High School Diploma with Associate's Degree or Bachelors of Science Degree preferred in chemical technology, biology, or related fields of study or equivalent combination of education and experience.

Experience:

• Minimum of 5+ years in a quality control lab or equivalent with capability to work independently with limited supervision. Experience with basic laboratory equipment and analytical testing techniques/procedures.

Knowledge/Skills/Competencies

• Requires ability to prioritize and to work efficiently;
• Good written and verbal communications skills. Good math skills.
• Ability to work independently and follow specific instructions.
• Basic project and time management skills.
• Learning on the Fly;
• Listening;
• Organizing;
• Action Oriented;
• Functional/Technical Skills;
• Time Management;
• Interpersonal Savvy;
• Customer Focus;
• Timely Decision Making;
• Planning;
• Problem Solving;
• Presentation Skills;
• Negotiating;
• Priority Setting;
• Drive for Results;
• Developing Direct Reports and Others;
• Cultivating Innovation;
• Delegation;
• Creativity
• Business Acumen;
• Conflict Management;

Knowledge of Industry & Regulation/ Quality Best Practice

• Broad knowledge of multiple analytical techniques;
• Requires highly proficient computer skills, particularly LIMS, MS Office, email, and Internet;
• Requires ISO 9000 and cGMP knowledge;
• Excellent knowledge & Experience in Quality Control with a total understanding of analytical chemistry.
• SAP advanced knowledge QM module Quality
• Excellent ability for managing, preparing, acquisition and interpretation of the samples for PRT and RMAC samples utilizing sophisticated analytical equipment - TQGCMS, TQLCMS, GCMS, etc.
• Excellent reporting the PRT results timely and preparation of monthly reports.
• Good knowledge of GPL / GPM Good practices of the laboratory, good practices of manufacturing, ISO standards, regulatory affairs, COFEPRIS
• Good Knowledge of HACCP Hazard Analysis and Critical Control Points, familiar with the allergens, contaminants declaration process

Project Management Skill

• Regression and acceptance testing cycle experience
• Skillful in Project Management
• Knowledge of Financial analysis, legal framework, and business drivers.
• Deep understanding of project people and Management knowledge
• Basic project and time management skills;
• Requires ability to perform several tasks at one time;
• Ability to work independently and follow specific instructions;

Supply Chain Management

• Know the whole flow of the supply chain management.
• Understand the critical control point.

Leadership & Decision making

• Decision-making based on the test result and provide workable suggestion.
• Ability to Influence teams and work in diverse groups of people & roles.
• Ability to work independently to manage work progression and time.
• Shows initiative beyond the scope of a project/task.

Coaching & Development

• Actively provides feedback to colleagues, is open to discussion & proactively recommends improvements.
• Actively solicits feedback from managers & others to prioritize improvements.
• Understands people & adapts feedback & managerial skills to accommodate various personalities.

Position Type/Expected Hours of Work

• This is a full-time position working a 12-hour rotating shift.

AAP/EEO Statement

Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace"

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

If you identify yourself in this position, please apply byuploading your resume and let's start the journey together!

Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.

Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws.

As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach.

To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com