USA - QA Manager QMS

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Indianapolis, Indiana
job type: Contract
salary: $72.56 - 85.37 per hour
work hours: 9 to 5
education: High School
 
responsibilities:
Description:

QA Manager QMS, Experienced quality document management system administrator Exemplify Company Values and Behaviors and other professional competencies in support of the document management system MasterControl.

• Ensure that the Quality System is compliant with the global guidelines and that all relevant regulations and legal requirements are adhered to.
• Ensure system validation from the vendor is maintained in compliance with CSV regulations.
• Monitor the periodic inspection and updating of the document management system relevant processes, continually improve and harmonize the quality-relevant processes, strengthen the awareness of quality, technical service, quality-relevant product tests, eliminate barriers relevant to the process and anticipate quality problems.
• Support the departments in case of Quality assurance questions.
• Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory compliance risks.
• Support a compliance and quality culture.
• Provides expert advice and input and harmonize and continuous optimize processes within Clinical Quality document management.
• Ensure compliance and further development, support, maintenance and constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPI and quality indicators (KQIs).
• Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way as the system administrator of the quality management document support system.

 
qualifications:

• Experience with MasterControl is required
• Quality document management is required
• Bachelors degree is preferred but not required if they have at least 5 years of experience with Quality systems and document management and control.
• Being Resilient Operational Excellence Knowledge of related industry GxP standards and processes Quality decision making.
• Knowledge of compliance requirements for all internal and external regulations and Quality Standards, including Risk Management assessment of the document management system and documents maintained as required in the system.
• Knowledge and support of decommissioning of document management system as the system administrator.

 
skills: Quality Assurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).