What are the responsibilities and job description for the Quality Assurance Senior Associate - Night Shift position at Infotree Global Solutions?
Description:
100% Onsite - Night shift starts 6:45 pm, Standard 12 hours rotation
Job Details: Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured at contract sites manufacturing on behalf of Client.Primary responsibilities of this position include translating technical documents such as batch records, investigations, change controls and complaints documentation into English. Some of these activities include communicating with the Client quality person stationed at the contract manufacturer facility. Specific language requirements will be noted in the additional comments section.; Skills: ; knowledge of process and faculty equipment, and the ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required in specific language needed
Basic Qualifications
High school/GED 4 years work experience or Associate 2 years work experience or Bachelor 6 months work experience or Masters Degree
Top 3 Must Have Skill Sets:
- cGMP, current Good Documentation Practice, Communication, Ability to follow written Procedure, some levels of Microsoft words knowledge, Team work, understand Standard Operating Procedures (SOP).
Day to Day Responsibilities:
Documentation review, Assist production activities for cGMP, follow procedures, Communicate throughout shift and relates information to incoming shift.