Quality Assurance Specialist 2

Curia Global Inc. (Rensselaer, NY) seeks a Quality Assurance Specialist II for its Rensselaer, NY location. The position is responsible for assisting with validation activities throughout the plant and coordinate appropriate support. Assist in completing validation activities and provide technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues.

Specifically, the Quality Assurance Specialist II will perform the following duties:

•    Develop and maintain a thorough understanding of cGMPs and associated regulations. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements;
•    Assist in cleaning, process and equipment validation activities throughout the plant. This includes development of validation strategies to align with the site operations and business priorities, coordinate and execute validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC as necessary;
•    Prepare and review validation plans, protocols and reports appropriate to define and document validation activities;
•    Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards;
•    Prepare and conduct Cleaning Validation Studies per Internal Master Plan;
•    Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems;
•    Use data analysis techniques and software, review test results to determine the main cause of defects, safety risks, and performance problems. Additionally, use the data to provide a risk assessment and check for adherence to regulatory standards;
•    Maintain validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing;
•    Manage and ensure validations plans are completed in accordance with project timetables;
•    Review and approve change controls and qualification/validation documentation. Authorize equipment for use and product release;
•    Provide training on validation issues and documentation;
•    Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, and applicable
project teams;
•    Track all validation documentation throughout the plant and follow-up as needed; 
•    Drive continuous improvement efforts for the site validation program;
•    Participate in self-development activities and training of others;
•    Exhibit safety awareness and safe work practices; 
•    Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business; and 
•    Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.

REQUIREMENTS     A Bachelor’s degree in Biomedical Engineering or a related field. Three (3) years of experience as a validation specialist or biomedical engineer, which includes 1 year of experience with the following:

•    Conducting root cause analysis and deviations;
•    Performing cleaning validation; and
•    Managing compliance with industry standards and maintaining Standard Operating Procedures (SOPs).

                                 OR

A Master’s Degree in Biomedical Engineering, or a related field. One (1) year of experience as a validation specialist or biomedical engineer, which includes 1 year of experience with the following:

•    Conducting root cause analysis and deviations;
•    Performing cleaning validation; and
•    Managing compliance with industry standards and maintaining Standard Operating Procedures (SOPs).

RATE OF PAY:     $102,149./year

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.