Quality Specialist

* Performs analytical reviews and approves cGMP finished product daily.
* Manages reclassification activities for materials produced by the Texas City plant.
* Submits Quality Assurance/Compliance SAP transactions.
* Reviews Quality procedures for compliance with regulations and guidelines.
* Documents and assists with product failure investigations, maintains databases, and then charts results.
* Contributes to maintaining the site’s product stability program.
* Support the Quality Manager with special projects.
* Coordinates quarterly Quality Assurance meetings. Track, follow up, then report action item progress generated during meetings.
* Maintains off-standard product summary and conducts periodic review with Supply Chain.
* Facilitates changes to SOPs, policies, training materials, and other Quality documents.
* Provides support on selected, large-scale projects involving data collection and/or research, small scope individual topics, and drafting recommendations to Quality Assurance management.
* Interfaces with other groups to resolve problems and drive continuous improvement.
* Participates in Safety and Environmental initiatives to contribute to compliance with State/Federal regulations and improve existing Company programs.
* Performs other related duties as assigned for the purpose of ensuring the efficient and effective functioning of the department.
* Assists with maintaining files and documents to upload to the Quality SharePoint site.
* Actively contributes to the organizational goals by taking initiative, executing on goals, and focusing on performance and safety.
* Improves the organization’s capacity and capabilities by building collaborative relationships, optimizing diverse talent, and leveraging positive communication and influence with others.
* A remote job. On-site availability and interaction are required.
* Not a management position – while you will collaborate with other team members, this is an individual contributor role with no direct reports.
* Not an entry-level position – we need a candidate to hit the ground running with solid experience and a background to prove it.
* Minimum four (4) years in Quality Assurance in a chemical or manufacturing-related industry.
* High School Diploma or equivalent
* Prior LIMS or similar database experience.
* Prior cGMP experience.
* Prior SAP and CAPA software experience.
* Established knowledge of Quality systems and approaches.
* Proven understanding ISO, cGMP and Food Safety requirements.
* Be an effective communicator, possess basic computer competencies, and be capable and willing to work outside of normal hours, weekends, and holidays, as may be required.
* Ability to respond appropriately during site emergencies as directed by the Site Emergency Manager, and have the ability to evacuate manufacturing process areas in a timely manner should an emergency arise.
* Ability to wear and properly utilize appropriate personal protective equipment if required to work or visit within the manufacturing process area.  This may include hard hats, safety glasses, respirators, earplugs, steel-toed shoes, or other equipment as required by the work and the location where it is being performed.
* Capability to lift 25 lbs., climb stairs, squat, and move comfortably within the work environment.
* A valid driver’s license to drive plant vehicles if necessary.
* Always demonstrate responsible and ethical behavior.
* The ability to help the company drive greater value through understanding the business, making complex decisions, and creating the new and different.
* Ability to travel as needed for training and compliance associated with the position.
* Must be authorized to work in the United States of America.
* Possess excellent interpersonal skills for interacting with numerous departments and management levels, as well as with customers, suppliers, and regulatory authorities.
* Able to handle multiple tasks simultaneously with a high degree of accuracy, along with excellent problem-solving skills for investigations.
* Able to organize and prioritize effectively while learning high-level aspects of new products/processes.
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