QA specialist II

Job Location
Frederick, MD
Job Description

This person will collaborate with the multi-disciplined peers to assure Quality standards are met in the production process, and utilize quality systems in compliance with current good manufacturing practices to promote a quality culture.

This role will be called upon to:
* Administer the change control and Deviation and corrective action systems for assigned products and quality systems.
* Maintains database; generates standard and ad hoc reports.
* Manages workflows to assure timely supply of product.
* Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
* Supports internal audits of manufacturing, analytical testing, labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program.
Responsibilities include:
* Document systems
* Change management
* Product manufacturing oversight
* Electronic system usage with tools such as Trackwise and SAP
* Product and raw material disposition
* Administration of the document management system
•Ability to learn the use of Operational Excellence tools such as DMAIC and root cause analysis.
•Ability to process map work flow and write Standard Operating Procedures (SOPs).
•Ability to communicate and work effectively with internal customers as well as third party laboratories and manufacturing sites.
•Demonstrated technical ability and skills in assigned work area to include product, process and/or testing knowledge.
•Ability review and understand analytical data.
•Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.


4 to 7 years of experience in Quality Assurance required
2 to 4 years of experience in manufacturing a plus
2 to 4 years of experience in validation a plus
Experience with a start-up or new facility a plus

Must be able to work in a cross functional team

Must be able to accommodate the schedule and demands of a production environment.

BS in pharmacy, science, engineering, or related field.


Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 9337 Position Category Operations - Quality

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