Job Description

Grace, a Standard Industries company, is a global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services that our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food ingredients and packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide.

Senior Quality Engineer

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. This includes resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, quality improvement programs, risk management, and assurance of cGMP and compliance.

This position is an integral member of the Quality Operations team. The support to site leadership and stakeholders enables Grace to produce high quality specialty chemicals such as pharmaceutical starting materials and food ingredients for our customers.

This is a high impact role, as the primary backup for the Plant Quality Assurance Manager. A leader and mentor, the Senior Quality Engineer is at the forefront of industry best practices for implementing and maintaining an effective Quality Management System. By leveraging their continuous improvement mindset, the Senior Quality Engineer will seek out process improvements and innovation.

Responsibilities

· Support achievement of quality goals and Key Performance Indicators.

· Assess compliance of practices and procedures with company policies and applicable regulations for the Quality areas under his/her responsibility.

· Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and segregates where appropriate.

· Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.

· Participates on Process teams as the Manufacturing Quality Assurance function. Functions may include leading/supporting process validation, equipment qualifications, and other applicable production and process controls.

· Approves standard operating procedures; ensures procedures comply with policy and make sense.

· Auditing of manufacturing documentation and quality records (calibration, validation, environmental controls, training, etc.). Member of the Internal audit team.

· Develops product quality plans, documents, and systems by creating product specifications, quality controls, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.

· Performs batch release.

• Support customer and regulatory audits/inspections.

Required Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering.

· 5+ Years of experience in a regulated industry in capacity of Manufacturing, Quality, or Engineering.

· Experience leading project teams across multiple functions and levels and managing competing priorities.

• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting pharmaceutical manufacturing.

· Knowledge of ISO 9001.

· Experience with risk management tools and techniques.

Preferred Qualifications

• ASQ certification (CQE or CQA).
• Lean Six Sigma training with Green or Black Belt certification.
• Expertise in quality management tools.
• In-depth knowledge of cGMP regulations; 21 CFR 210 /211, 117, 820, ICH Q7.

Physical Requirements and Environment

· Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator.

· The Senior Quality Engineer is an onsite role. 

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