QA Compliance Specialist in Burlington, MA at AMRI

Date Posted: 5/12/2020

Job Snapshot

Job Description

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

The Quality Assurance Compliance Specialist will work under the direction of Quality leadership on projects in the delivery of GMP quality assurance and regulatory compliance. This individual will be responsible for organizing and coordinating the Supplier Quality and Audit program. Responsibilities include overseeing compliance related initiatives, such as the internal auditing program, as well as external audits, approved supplier list, quality agreements, and annual product reviews. Additional responsibilities include supporting the development of GMP training matrices, delivering GMP training, SOP development and/or revisions, and other tasks as delegated by the Quality Assurance Associate Director. This individual will have the opportunity to work and coordinate key activities across the site. 

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. 

Responsibilities

•Responsibilities include development of an annual schedule, coordinating internal and supplier audits, and reporting on internal and supplier audit schedule adherence
•Oversee the internal and supplier auditing program
•Implement Global polices pertaining to supplier qualifications
•Support external audits (regulatory bodies and client audits) on an as needed basis in the front room
•Responsibilities may include Hosting external audit and/or managing and coordinating the war room activities
•Management of supplier and client Quality agreements and drafting Annual Product reviews as required
•Must be able to function independently or in a larger cross-functional group
•Must be detail-oriented, able to work in a fast-paced environment, complete assignments within department cycle times and maintain a high level of quality detailed documentation
•Responsible for tracking metrics for the Quality department and presenting to management
•Drafting and/or reviewing product complaints and managing on time closure
•Oversee the implementation for new parts at AMRI Burlington

Qualifications
•Bachelor’s Degree in life sciences strongly preferred, or equivalent experience
•3-5 years of relevant experience in the pharmaceutical industry
•Working knowledge of quality assurance, quality systems, and auditing
•Ability to work semi-independently, and have demonstrated ability to interact with others in a cross-functional environment
•Solid knowledge in FDA regulations, especially the cGMP for the 21st century initiatives as well as global GMP and Eudralex 4
•Strong knowledge in the application of phase appropriate, risk based principles
•Proficient in Microsoft Office
•Proficient in TrackWise/TrackWise Digital

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-MA-Burlington
Other Locations:
Organization: AMRI Burlington
Schedule: Full-time
Job Posting: May 26, 2020, 2:49:38 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.