Senior Quality Assurance Specialist in Albany, NY at AMRI

Date Posted: 5/18/2020

Job Snapshot

Job Description

Description

SENIOR QUALITY ASSURANCE SPECIALIST in Albany, NY

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

The Sr. Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by ensuring compliance with cGMPs, Company and customer quality standards as well as external regulatory requirements.

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:

  • Perform internal and external audit and develop programs and prepare reports as required.  Participate in the Annual Quality Systems audit program.  This includes the preparation of Audit Plans, conducting audits and writing Audit reports.

  • Assist with Regulatory and Customer audits as required.  Assist in preparing and provide assigned audit responses to observations.

  • 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.

  • Review and approve master and production batch records. Assist in the development of records with operations as needed.

  • Disposition of final intermediates and APIs (includes review of all associated documentation).

  • Create, Review and approve deviations and investigations. Function as QA lead for Quality Events.  Compile data, prepare and review trends.  Identify areas of concern and communicate to management.

  • Create, review and approve change controls.

  • Create, review and approve material release specifications and certificates of analysis.

  • Review and approve equipment qualification documentation, including protocols and reports.

  • Review and approve SOPs.  Write SOPs as required.

  • Assist in resolving quality problems/concerns with quality control and manufacturing personnel.






 
Qualifications

Education and/or Experience:


  •       BS degree in Life Sciences
  •       A minimum of 7 years GxP experience in an FDA-regulated pharmaceutical environment.

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.



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.

Job: Quality
Primary Location: US-NY-Albany
Other Locations:
Organization: AMRI Albany
Schedule: Full-time
Job Posting: May 18, 2020, 2:49:43 PM
Shift Type: Standard 8

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.