QA Specialist/Technician Fenton, Missouri
Job Ref: 36423
Quality Assurance Specialist
Function: The Quality Assurance Specialist will be responsible for ensuring day to day quality assurance activities are executed in compliance with all applicable regulations.
Essential Functions of the Position:
- Maintain and act as administrator of the employee training records (electronic training management/paper).
- Maintain compliance oversight (auditing responsibility) of the training program.
- Provide training on quality assurance and FDA compliance topics.
- Oversight of the vendor management program.
- Conduct internal and vendor auditing.
- Ensure that daily Quality Assurance Departmental activities support operational requirements (componentry inspection and release, document control system, label issuance/control, etc.).
- Perform batch record issuance/review to ensure all products meet company/regulatory standards and customer expectations.
- Complete investigations and failure analyses so that root causes for deviations are understood and eliminated where possible.
- Write standard operating procedures.
- Support label control program to assure compliance with issuance accountability, change and processing controls.
- Disposition raw materials for use in pharmaceutical goods.
- Review and approve analytical method validations.
- Support Quality Manager in assuring that requirements of the Code of Federal Regulations are met.
- Other duties, which may be assigned from time to time.
Skills and Abilities Required:
- Knowledge of Federal and State Regulations
- Knowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies
- Strong organizational skills with high attention to detail
- Strong communication skills
- Possess excellent computer (MS office: Word; Excel; Access; Outlook), writing and editing skills
Minimum Education and Experience Required:
- Minimum Education: Bachelor’s degree
- Minimum 2 years Quality Assurance experience in a regulated environment
- Ability to physically work in an FDA regulated environment.
- Ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
- May be required to sit or stand for long periods of time.
- Some lifting <25lbs.
- Ability to see accurately and in color, and have good hand eye coordination.