Validation Specialist in Springfield, MO at AMRI

Date Posted: 7/30/2019

Job Snapshot

Job Description



 

QA Validation Specialist, Springfield, MO

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

As the QA Validation Specialist, you will support validation activities throughout the plant, assist in defining, completing and documenting validation activities, and provide technical assistance to Engineering, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

In this role, you will;

  • Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. 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 coordinating validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.

  • 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

  • Using data analysis techniques and software, review test results to determine the main cause of defects, safety risks, and performance problems. They also 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.

  • 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.

  • Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.

  • Manage and complete each assigned Annual Product Review (APR) section related to validation. This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures.

  • Review and approve deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management.

Job Requirements

Required:

  • BS Chemical or Mechanical Engineering

  •  2-5 years validation experience

  • Demonstrated interpersonal skills

  • Computer literate with a functional ability with word processing, spreadsheets, project scheduling, database and presentation software


    All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.


Shift:  

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.