Quality Assurance Specialist in Rensselaer, NY

Date Posted: 10/07/2020

Job Snapshot

  • Employee Type:
    Full-time
  • Location:
    Rensselaer, NY
  • Job Type:
    Quality
  • Experience:
    Individual Contributor
  • Date Posted:
    10/07/2020

Job Description

Description

Quality Assurance Specialist, Rensselaer NY  AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by ensuring proper implementation of the quality systems at the site, maintains them current and in line with applicable regulation and Corporate standards. 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.
As the Quality Assurance Specialist, you will:
• Work with Quality Supervisors and Manager in ensuring compliance with all Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site
• Develop and/or review and/or approve quality standards, policies, and procedures for functions and departments involved in cGMP activities.
• Support Regulatory Agency inspections at the site and the preparation of CAPAs, and monitor their completion providing regular updates to direct supervisors.
• Participate in customer audits at the site with preparation of CAPAs, and monitor their completion providing updates to customers and management.
• Report serious or repeated observations or serious compliance gaps to Head of Quality Assurance.
• Maintain evidence files for all regulatory inspections and customer audits.
• Interact with the AMRI Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within AMRI.

Qualifications

Qualifications:
• Minimum Bachelor of Science degree in Chemistry or a related field
• Minimum 3 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities
• Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
• Knowledge of pharmaceutical processes.
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
• Proficient in building consensus, negotiating and escalating issues
• Good understanding of the importance and use of quality metrics
Preferred Qualifications:
• Auditing experience is preferred All interested applicants must apply online.  AMRI is an Equal Opportunity Employer.  All qualified applicantswill 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.


Job: Quality
Primary Location: Rensselaer, New York
Schedule: Full-time
Job Posting: 10/07/2020
Shift Type:

AMRI 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.

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