Documentation Specialist/Reviewer


Job ID 18-00037

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

ESSENTIAL RESPONSIBILITIES
% OF TIME -FREQUENCY - TASKS

60% - Daily - Review method validation, method development documents, protcol, report,standard test proceture, specification batch record, ANDA filling documents
20% - Daily - plan, design and execute experiments for Analytical method development, validation, formulation development support and Analyze data and summarize in form of reports
10% - Daily - Review literature, guidelines, reports, protocols and approve them
5% - Daily - Discuss, prioritize and plan work with external functions such as RD, TS & Manufacturing
5% - Weekly - Provide feedback to senior management on project progress
5% - Daily - Update DEA daily inventory
5% - Monthly - Provide monthly DEA inventory
OTHER RESPONSIBILITIES
Suggest improvements and efficiencies in the department. Assist in revising and maintaining SOPs, operating procedures and other documents. Controlled substance inventory and handling. Document specialists store, manage and track company documents.



Qualifications

QUALIFICATIONS
Minimum of 2-3 years experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements. Thorough knowledge of cGMP and GLP. Experience working with Microsoft software (Word, Excel, Access, Project). Maintain paper based and electronic filing systems. 
Review of documentation generated during method validation, method verification, stability testing, routine testing and other analyses. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. 
Provide feedback from reviews to analysts and supervisor and ensure necessary action are taken to correct or prevent error.Review data using a systematic approach to ensure compliance with procedures and specifications. Review and audit logbook, calibration, chemicals expiry as required. Perform other duties assigned by supervisor as needed. Ability to work in a team with excellent spoken and written communication skills. 
This person should have previous experience of writing STP, specification, protocol and report as per cGMP. 
LICENSES, CERTS & MEMBERSHIPS
BS, MS or PhD in Analytical Chemistry or related field 
LEADERSHIP SKILLS & ABILITIES 
Must have problem solving capabilities. Must demonstrate Thinking out-of-the-box and being able to coordinate crossfunctionally in order to achieve set timelines effectively. 
MANAGEMENT SKILLS & ABILITIES 
Must be able to work as part of a team as well as lead the team when necessary. Must be able to handle competing priorities effectively. Should be able to think clearly under pressure.