Quality Assurance Specialist II in West Lafayette, IN at AMRI

Date Posted: 5/24/2020

Job Snapshot

Job Description

Description
QUALITY SPECIALIST II in West Lafayette, IN

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

The Quality Assurance Specialist II is an integral part of the AMRI team, contributing to our success by performing cGMP review of lab operations to ensure appropriate reports/data/processes to conform with SOP's and guidelines. Role serves as important function to maintain appropriate regulatory documentation.

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 QA audits of scientific reports/data to ensure cGMP compliance in preparation for release of the reports to the customer
  • Develop, implement, and revise procedures (SOPs, Methods, etc.)
  • Conduct investigations and internal audits of quality systems
  • Review equipment and software qualification and validation protocols
  • Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data
  • Designs and plans audits of simple quality systems for review with QA management
  • Conducts employee training sessions as necessary

Qualifications

Qualifications and background to be successful in this role:

 

  • BS degree (chemistry or other related scientific field preferred)
  • Demonstrated proficiency in oral and written communication skills producing effective interaction with others at all levels




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-IN-West Lafayette
Other Locations:
Organization: AMRI West Lafayette
Schedule: Full-time
Job Posting: Mar 24, 2020, 10:01:44 AM
Shift Type: Standard 8

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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.