Sr QA Specialist

UNIVERSITY OF MARYLAND BIOTECHNOLOGY INSTITUTECenter for Advanced Research in Biotechnology

Rockville, Maryland

 

VACANCY ANNOUNCEMENT



 

 

Title: Sr. Quality Assurance Specialist

 

Category: Regular, Exempt Staff

 

Qualifications:

 BS in Chemistry, Biology or related field 1 year of QA experience within an FDA regulated environment 3 years of GLP/GMP experience is required

 Solid investigation and writing skillsGood oral communication skills are essentialCandidate must demonstrate strong attention to detailMust be PC literateCandidate must also possess ability to effectively and efficiently manage multiple tasks and deadlinesMust work well independently and within a group

 

Responsibilities:

 

Incumbent will be responsible for the following:

 

? Supporting the authoring, reviewing, and/or revision of controlled documents, to include SOPs, batch records and forms; Maintaining the quality system document storage and retention system and ensuring that various departments are advised of pending documentation requirements

 

? Reviewing analytical data, in-process documentation and batch records to evaluate non-conformances, including deviations, out-of-specification analytical results, and environmental excursions

 

? Working in conjunction with QC and Manufacturing to assure that raw materials, in-process components and final products are fully qualified and released according to schedule

 

? Assisting in conducting audits for program facilities and operations in addition to vendor compliance inspections

 

? Demonstrating initiative in continuous improvement efforts

 

? Assisting with preparation of training materials and conduction of training sessions

 

Salary: Commensurate with experience

 

Position Available: Upon Completion of Search Applications

 

Qualified applicants should send a letter of interest (referencing position# 300853), resume, and the names and contact information of three references by e-mail to:



carbsrch@umbi.umd.edu

 

Closing Date: Application review will begin on August 11, 2006, and will continue until a suitable candidate is selected.

 

Visit our website at www.umbi.umd.edu

 

UMBI is committed to affirmative action and equal opportunity employment. As required by the 1986 Immigration Act, applicants should be prepared to present acceptable documentation showing their identities, their U.S citizenship or alien status, and their authorization to work in the United States.