Sr. Quality Assurance Specialist in Rensselaer, NY at AMRI

Date Posted: 11/12/2018

Job Snapshot

Job Description

The Senior Quality Assurance Specialist (Investigations), with guidance from the site Quality Head, is primarily responsible for managing the site quality investigations, including review and approval of investigation records, active participation in root cause identification, CAPA assignments, CAPA follow-ups, and verification of CAPA effectiveness.

MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Reviews and approves investigations

• Facilitates investigation by coordinating investigation meetings with the involved parties to ensure a thorough and complete investigation is conducted

• Proactively collaborates with the applicable department to determine root cause

• Ensures that investigations tools (such as Fishbone, 5 Whys, is/is not, casual diagram) are utilized correctly and consistently for root cause analysis, and they are documented

• Continuously monitors, tracks and trends investigations, analyzes data around frequency of quality events and primary/secondary root causes (using Pareto charts or equivalents)

• Monitors and tracks progress of the investigation activities and ensures that they are closed on time

• Continuously monitors and provides management with periodic updates on investigation incidence, root causes and identifies opportunities for improvement.

Job Requirements

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• Minimum B.Sc. degree in Chemistry or related field

• Minimum 5 years QA experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities

• Working knowledge of Microsoft Excel, statistical analysis

• Working knowledge of investigation and cause-analysis tools (such as Fishbone, 5 Whys, is/is not, casual diagram)

• Strong communication and collaboration skills

• Excellent organizational skills

• Proven ability to interact with internal stakeholders, upper management, customers and regulatory agencies

• Proven ability to work and manage tasks independently

• Proven working experience with quality documentation

• Strong knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7, ISO 13485), guidelines (e.g., FDA, ICH), and Quality Systems



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.