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QA Validation Specialist in Rensselaer, NY at AMRI

Date Posted: 6/11/2019

Job Snapshot

Job Description

QA Validation Specialist, Rensselaer NY 


The QA Validation Specialist, assists with the validation activities throughout the plant, coordinates appropriate support and assists in completing validation activities and provides technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues. Serves as a source of expertise in the group for validating new systems /Processes.


  • Primary responsibility is to provide quality review & approval of validation activities associated with changes to existing systems & projects that support site
  • Support protocol development & approval, investigations for deviations & champion local, corporate & regulatory standards
  • Presentation & support for validation concepts & approaches with audits & inspections
  • Provide Quality validation review & approval through the preparation, execution, data analysis, & report writing for IQ, OQ & PQ protocols
  • Quality review & approval of Change Requests (CR’s) related to project validation & other validation activities for the site
  • Perform compliance & technical reviews/approvals of protocols & protocol data
  • Review & approve validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Review & approve specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes & the validation.
  • Identify process improvements before equipment, systems or processes are placed under change control during validation.
  • Manage and complete each assigned Annual Product Review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures.

MAJOR DUTIES AND RESPONSIBILITIES


Job Requirements

Education and/or Experience

  • Bachelors of Science degree in Chemistry, Engineering or a related field.
  • Experience: Minimum 5 years’ experience in pharmaceutical environment. API industry is preferable.  At least 2-3 years of experience in validation, Quality related discipline or drug development experience is MUST.
  • Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in quality concepts including technical & compliance review of documents, expert competence in one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation). Expert in cGMP documentation practices. 



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:  First 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.