We are a Texas based privately owned Chemical Manufacturing Company in business since 1921. We are a leading manufacturer and supplier of private branded cleaning and maintenance chemicals, disinfectants, sanitizers, hand soaps, and programs to the sanitary maintenance industry. Our Garland facility is seeking a talented and motivated QA Specialist to join our Quality Assurance department. The ideal candidate functionally understands current GMPs and has experience in implementing these practices into Quality Assurance (QA) policies and procedures, SOPs, and Carroll Company’s Standard Requirement Documents.
Interact with management and other personnel to coordinate the activities of Quality Assurance with those of other departments within the company.
Provide direction and lead the development and implementation of quality systems that meet, company, customer and regulatory requirements.
Provide technical support to the Quality Control operation.
Provide support to programs aimed at the improvement and creation of Quality System documentation.
Create Quality System documents as required.
Train Quality Control and Quality Assurance personnel on new scientific and quality techniques.
Interact with suppliers on quality issues and specifications.
Interact with customers on quality issues and specification.
Provide scientific and technical support to management team.
Support development of continuous quality improvement programs.
Assist with inspections by regulatory authorities.
Review and approve the Validation, Stability, Sample Retain and Customer Complaint documentation.
Review and approve production documentation and specifications to ensure compliance with Company and regulatory requirements.
Coordinate the Change Control program and review associated documentation.
Coordinate the Corrective and Preventative Action Program, perform investigations, prepare investigation reports, and review.
Coordinate the Standard Operating Procedure program and review and approve associated documentation.
Assist with development and execution of training programs.
Maintain quality system reports and prepare quarterly reports for Senior Management.
Track and Trend quality data and report to management.
Preferred minimum of two years hands – on experience in Quality Assurance at a regulated company.
Preferred B.S. in Chemistry or related scientific discipline.
Prefer minimum two years direct work experience in a regulated Quality Assurance department, including work in a wet – chemical, HPLC or GLC laboratory and in a plant setting. Willingness to work in production as needed to assist with the improvement of manufacturing techniques and equipment.
Prefer familiarity with the types of products Carroll Co. manufactures and with the raw materials used by the Carroll Co.
Conversant with microbiological testing of consumer and OTC drug products.
Excellent written and verbal communication skills in English. Bilingual in Spanish is a plus.
Excellent computer skills in Microsoft Office.
Well organized and self-directing method of work.
Strong leadership skills.
Self-starting and the ability to think out – of – the – box.
Familiar with Statistical Process Control and its application to chemical product manufacturing operations.
Strong drug cGMP knowledge, familiarity with GLP requirements of the EPA and with EPA regulations as they apply to Carroll Co. products.
Excellent people skills. Comfortable working with Senior Management, customers and line workers in the plant.
Direct experience with preparation of Standard Operating Procedures.
Direct experience with implementation and operation of CAPA, Change Control and Deviation Control systems.
Very detailed in review, approval and preparation of quality documentation.
Able to multitask as required. Unfazed by multiple demands of management at the same time.
Job description statements are intended to describe the general nature and level of work being performed by employees assigned to this job title. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
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