Quality Assurance Documentation Specialist
at Albany Molecular Research, Inc

Date Posted: 8/17/2017

Job Description

Quality Assurance Documentation Specialist in Lebanon, NJ

The leader in testing, Whitehouse Laboratories has business units that provide support for testing from development to market – from analytical chemistry, material qualification, to simulated distribution, Whitehouse Laboratories is the testing partner to manufacturing companies.   

SUMMARY OF FUNCTIONS:

•Ensure integrity of Quality Assurance Documents and assist Quality Assurance Unit in maintaining Quality Systems in accordance with FDA regulations.
Responsibilities include, but are not limited to the following: 

•Responsible for retention, archiving and maintenance of all quality documents for the Quality Assurance Department.
•Responsible for coordinating new hire training and maintaining all training records.
•Responsible for tracking scheduled revisions of Standard Operating Procedures, preparing and issuing SOPs. 
•Responsible for issuing controlled quality documents to laboratory personnel.     
•Support QA during quality system audits and third party inspections. 
•Assist and support and compile data for various quality system reports, presentations and or global regulatory needs. 
•Assist and maintain files such as Internal Audit, CAPA, Vendor Assessment and Monitoring files.
•Other duties as assigned by QA Management.

ORGANIZATIONAL RELATIONSHIPS:
•Reports to the Quality Assurance Department Head

Job Requirements

EDUCATIONAL OR SKILL REQUIREMENTS:
•A college degree is required with a major in science preferred.  
•1-2 years of industry QA experience is required.  
•A comprehensive understanding and working knowledge of the cGMP’s is a preferred. Strong computer, scientific, and organizational skills; Proficient in IT applications such as MS Word, Excel, PowerPoint, Access. 
•Excellent communication (oral and written) and attention to detail
•Ability to work independently and as part as a team, self-motivated, adaptability, and a positive attitude
•Ability to learn new techniques, perform multiple task simultaneously, keep accurate records, follow instructions, and comply with company policies.


Shift:  First Shift

Job Snapshot

About Us

For more than 20 years, AMRI has provided integrated drug discovery, development and manufacturing services – all while adapting to the rapidly changing needs of the pharmaceutical, biotechnology and related industries.

AMRI is a continually evolving organization and always looking for talented people. The company provides equal employment opportunities to all individuals without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, citizenship or any other characteristic protected by law. To ensure that employment decisions are consistent with equal employment opportunities, AMRI imposes only job-related requirements for these opportunities.

If you would enjoy working for a company devoted to delivering better outcomes for the pharma industry, and if you are looking to join a global team of dedicated professionals, we invite you to join the Albany Molecular Research Talent Network today!

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