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R&D QA Manager

Location: 

Elwood, IL, US, 60421

 

Demonstrates ability to apply extensive expertise with significant breadth or depth in quality system requirements and ensures Stepan pharma grade product meets quality requirements consistently. Adapts problem solving approach to identify solutions. Works with manufacturing and quality control effectively to meet production and shipping schedule. This role is within our R&D department that is located at our flagship plant in Elwood, IL. 

 

Major / Functional Responsibilities:

·Ensures relevant training is conducted to all relevant personnel as outlined by the quality system

·Develops excellent working relationships with Stepan manufacturing, quality control and customer.

·Excellent writing skills; can explain technical issues and resolution, rationale in concise documentation

·Effectively utilizes statistic tools for data analysis

·Acquire a broad knowledge of manufacturing, quality, compliance with regulatory requirements with an understanding of Quality and GMP applicable within the pharmaceutical industry.

·Communicate quality and business related issue or opportunities to management.

·Interact with customers and suppliers on quality and compliance matters.

·Collect and analyze plant data for significant quality trends and report conclusions in campaign reviews.

·Maintain all historical records as required.

·Review and approve documentation critical for batch release. Ensure that all batch implicating issues are highlighted and resolved without impact to compliance/regulatory requirements.

·Lead and or support with initiation and completion of NCRs, CAPAs and Internal audit findings. Track CAPAs/action items to satisfactory completion and verification/effectiveness checks.

·Lead Root Cause Analysis investigations for quality incidents, customer complaints, and other non-conformances. Write final investigation reports based on investigation information.

·Plan, develop, revise, review, implement, and maintain standard operating procedures. Notify impacted employees of changes and required training.

·Coordinate and support internal/external audits and inspections. Conduct gap analyses, assess risks associated with gaps, and establish action plans to address risks to support inspection readiness.

 

Qualifications:

Degree or Advanced degree in chemical engineering or related discipline. BS in chemistry, biochemistry, biology or chemical engineering or related field and 7+ years, MS and 5+ years.

cGMP experience required

 

Travel: 25%

Established in 1932, Stepan Company is a major manufacturer of basic and intermediate chemicals including surfactants, polymers, as well as specialty ingredients that go into consumer, household, and institutional products such as laundry detergents, shampoos, and surface cleaners. Stepan Company currently has 20 global manufacturing locations and over 2,000 employees. We have a strong record of growth. Our growth allows us to provide meaningful career opportunities and stability to our team members. We have big goals at Stepan and know every team member will be crucial to achieving our objectives. Regardless of function, we are looking for team members who bring with them a growth mindset, an entrepreneurial spirit, and the ability to thrive in an evolving environment.

 

We celebrate diversity at Stepan and are committed to creating a diverse, inclusive environment. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, genetic information, disability, age, veteran status, or any other status protected by applicable law.

 

 

 

 

Stepan is a global specialty and intermediate chemical manufacturer that has been serving a broad range of industries for 88 years. Today, Stepan is a $2 billion revenue company. Our continued success is driven by the passion and commitment of our 2,200 employees around the world.

Why Work At Stepan?

  1. Stable & Growing
  2. Collaborative Environment
  3. Make a Difference & Be Recognized
  4. Committed to Safety & Sustainability
  5. Value Driven Culture

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Nearest Major Market: Chicago