Quality Assurance Specialist

Chemisphere Corporation    St. Louis, MO
Job Description

Chemisphere Corporation is seeking to employ a Quality Assurance Specialist to assist with continuing GMP, FSMA and other quality activities. This is a full time position, reporting to the Quality/Technical Manager.

Key Responsibilities

* Draft Quality-related policies and standard procedures

* Maintain continuing awareness of industry and government quality practices and standards

* Develop, monitor, improve and maintain company procedures to ensure compliance with FDA Good Manufacturing Practice and GFSI/FSMA certification requirements

* Lead implementation of quality-related procedures

* Lead review and management of documents to ensure compliance with company policies/practices and relevant standards and quidelines. These documents include but are not limited to:

*Standard Operating Procedures

*CAPA and Complaints

*Batch Records, Production Material Specifications

*Data and testing logs, Calibration records

*Process and equipment validation

* Perform and document internal audits and other quality assurance activities

* Collect and analyze data to identify areas for improvement in the quality system

* Identify training needs and organize/coordinate training in quality procedures, cGMP requirements, and QA concepts across functional groups.

* Coordinate and support on-site audits and inspections conducted by third-party providers, government regulatory agencies and customers

*Assist Quality/Technical Manager with hosting activities

*Evaluate audit findings and coordinate activities with company management to prepare and implement appropriate corrective actions

* Coordinate and maintain supplier approval database, including

*Questionnaire/validation database

*Perform follow-up external quality audits as needed

* Collect and compile statistical quality data for reporting to management

Education and Experience

* Minimum Bachelor s degree in science-related field

* Chemistry, Chemical Engineering, Biology, Biochemistry recommended

* At least 4 years of experience in Quality Assurance required in related industry

* Cosmetics, pharmaceuticals, chemical/petrochemical, food

* Clear understanding of GMP and Quality accreditation systems

* Writing and implementing Quality standard procedures

* Quality inspection and auditing experience

* Knowledge of tools, concepts and methodologies of Quality Assurance

* Quality certifications an advantage

Other Competencies:

* Attention to detail

* Excellent planning and organizational skills

* Excellent communication skills

* Adaptable team player

* Ability to work with limited supervision

* Strong computer skills including Microsoft Office, QA applications

Chemisphere offers great benefits including Health, Dental and life insurance, 401K plan with a company match.

Job Type: Full-time


  • Quality Assurance: 4 years (Required)

  • Fri, 15 Mar 2019 21:48:51 GMT

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