QA Manager


Job ID 18-00109

Industry Pharma

Job Type Permanent

Location Durham, NC

Description

SUMMARY 
This position is an important Quality Assurance Management team, to ensure that products manufactured and distributed by Client meets all required cGMP conditions and product specification limits. This position will take active participation in the resolution of deviations and evaluate the conclusion of the investigation prior to determining product status. This position will direct and lead the documentation group of QA. The position will also be involved with coaching of department personnel and also assisting the training of manufacturing personnel on why cGMP requirements must be followed. 
REPORTING RELATIONSHIPS 
Direct reports 0-5 
Indirect reports 3-11 
DUTIES & ESSENTIAL JOB FUNCTIONS 

Mentoring, Coaching and training of department employees 
Review of Batch Records and approve product disposition 
Release of raw materials, components, in-process materials and finished products 
Review and approve investigation reports as applicable 
Assist in operational investigations to ensure timely completion 
Ensure plant compliance with cGMP requirements at all operational areas of the plant 
Review Master Batch Record revisions or new creations to ensure consistency and accuracy as per the supporting document 
ESSENTIAL DUTIES
10% Weekly Mentoring, Coaching and training of department employees 
10% Weekly Review of Batch Records and approve product disposition 
45% Weekly Review and approve QA documentation a applicable, which can include change controls, deviations, incidents, protocols, cleaning verifications/validations, SOPs and snecification. 
20% Weekly Assist in operational investigations to ensure timely completion 
15% Weekly Ensure plant compliance with cGMP requirements at all operational areas of the plant 
OTHER FUNCTIONS AND RESPONSIBILITIES 
Other job responsibilities as assigned by the department head 



Qualifications

QUALIFICATIONS 
BS/BA in Science 
REQUIRED 

Minimun 3 years experience in solid dose Pharmaceutical Manufacturing Industry as Quality Assurance Manager/ Assistant Manager/ Supervisor 
Have ability to communicate effectively orally and in writing 
Have ability to motivate personnel to work together 
Possess organization skill 
Possess analytical mind to deal with issues and offer solutions 
PREFERRED 
Experience on deviation investigations 
Ability to train personnel on GMP regulations and requirements 
Technical writing skill 
ANY REQUIRED LICENSES/CERTIFICATIONS 
Not Applicable