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Quality & Excipient GMP Coordinator

The Dow Chemical Company has an exciting opportunity for a Quality & Excipient GMP Coordinator, located in Croydon, Pennsylvania. This position leads and execute the business, site and plant/department quality programs as defined in the Manage Product Quality (MPQ) Business Quality Strategy to enable the business to profitably meet customer and product regulatory requirements related to the quality management system. Lead/coordinate the successful implementation of the Excipient Good Manufacturing Practices (GMP) at the Croydon Emulsions facility and two toll manufacturing facilities in the area. This role also serves as the people leader for the Analytical personnel. This position also enhances the front line knowledge and accountability for quality. Promote a customer-focused culture within the plant. Ensure that the Excipient GMP is effectively implemented at Croydon and within the Dow Coating Materials (DCM) business.
Responsibilities include:
Implement and maintain the business/site quality programs which align to the MPQ Business Quality Strategy at the plant level.
Provide an effective interface between customers and the plant to ensure consistent high quality service to customers. Represent the "Voice of Customer" at the plant.
Act as key plant interface to build or enhance relationships, services and flow of information between the plant and the customer, purchasing, supply chain, research, product stewardship and commercial organization related to the product quality / regulatory requirements related to the quality management system.
Generate and use quality data (customer complaints, plant metrics etc.) to enable cross functional partners to drive product quality improvements.
Lead and participate in management of change reviews that potentially impact product quality (e.g. specification, train qualifications, plant equipment / systems, analytical testing, etc.).
Host customer and other quality related external party visits and audits, in cooperation with Commercial and other functions.
Lead / champion product quality problem solving efforts (i.e. Corrective Action Management Process, the Root Cause Investigation Process, including customer feedback, etc.).
Establish and manage the plant quality system audit program, in conjunction with Business or Site strategies
Finalize implementation of management systems to support Excipient Policy implementation.
Work with plant technical resources to develop systems to support Excipient product validation activities and coordinate process validation for all the Excipient products.
Perform and document reviews required before Excipient product release: raw material acceptance, manufacturing records, packaging and labeling.
Ensure proper disposition of out-of-specification material and maintain relevant records.
Work with the Dow External Manufacturing Operations Leader to implement and maintain systems to support Excipient production at 3rd party operations.
Serve as element focal point for the Cosmetic and Excipient requirements of the Operating Discipline Management System.
Ensure plant Operating Discipline system, procedures and guidelines meet quality system requirements in compliance with Excipient GMPs.
Act as key plant interface to build or enhance relationships, services and flow of information between the plant and the customer, purchasing, supply chain, research, product stewardship and commercial organization related to Cosmetic/Excipient requirements.
Support internal and customers audits and visits from regulatory agencies of plants and external manufacturing facilities. Work with facilities on gap-closing projects.
Drive investigations and product assessments as needed for Cosmetic/Excipient products.
Manage retain samples required to address customer inquiries. Audit 3rd party warehouses as required.
Serve as a role model for EH&S, share learning, and ensure follow-up on incident investigations.
Provide people leadership for analytical roles
Manage analytical prime controllable expenses
Coordinate capital planning and serve as a focal point for procurement of analytical equipment
Critical Success factors:
This is a key role to ensure that the business, site, and plant quality programs are effectively implemented for the plant. Generates enthusiasm and the ability to lead and maintain a quality program, without people reporting authority.
The job requires out of the box thinking, strong interpersonal skill across all functions and levels, constructive gate-keeping skills, sound technical skills (product and technology of quality management), as well as strong corporate core competencies in collaborating for superior results, leading courageously, delivering innovative solutions and generating customer value.
Typically, this role spends a significant portion amount of its time dealing with cross functional activities, external to the plant.
Required Qualifications:
A Bachelor's degree with a discipline in a STEM (Science, Technology, Engineering, Mathematics) is required.
A minimum of 3 or more years of quality or manufacturing related experience is required.
This is a key role to ensure that the business, site, and plant quality programs are effectively implemented for the plant. Generates enthusiasm and the ability to lead and maintain a quality program, without people reporting authority is required.
The job requires out of the box thinking, strong interpersonal skill across all functions and levels, constructive gate-keeping skills, sound technical skills (product and technology of quality management), as well as strong corporate core competencies in collaborating for superior results, leading courageously, delivering innovative solutions and generating customer value.
Typically, this role spends a significant portion amount of its time dealing with cross functional activities, external to the plant.
A minimum requirement for this U.S. based position is the ability to work legally in the United States. No visa sponsorship/support is available for this position, including for any type of U.S. permanent residency (green card) process.
About DowDuPont
DowDuPont (NYSE: DWDP) is a holding company comprised of The Dow Chemical Company and DuPont with the intent to form strong, independent, publicly traded companies in agriculture, materials science and specialty products sectors that will lead their respective industries through productive, science-based innovation to meet the needs of customers and help solve global challenges. For more information, please visit us at http://www.dow-dupont.com/.
The positions represented by this job posting are aligned to one of the three divisions, Agriculture, Materials Science or Specialty Products, which are expected to separate from DowDuPont into stand-alone public companies. Information on the division alignment will be provided during the recruitment process.
Dow Offers:
Competitive salaries and comprehensive benefits.
An annual variable pay program that rewards team and individual performance while sharing success across the company.
Employee stock ownership - and the commitment to long-term success that it brings.
On-going learning opportunities within a diverse, inclusive and rewarding work environment.
Career experiences that can span different Dow businesses and functions with opportunities for personal and professional growth.
The chance to work within a global company and interact with colleagues from around the world.
Opportunities that spark your imagination and ignite your passion to help others.
Dow is an Equal Employment Opportunity Employer.
As part of our dedication to the diversity of our workforce, Dow is committed to Equal Employment Opportunity without regard for race, color, national origin, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity, or religion. We are also committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at http://www.dow.com/en-us/contact-us, you may call us at 1 800-523-3945 and select Option 1, or send a facsimile request to 1 989-636-3674.

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