Creates, updates and peer reviews Master Packaging Instructions, forms, and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Packaging Instructions and specifications.Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements.Assist with creating and/or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts.Assist as company liaison with customers concerning quality control documentation.Help identify, communicate, track, and resolve document related issues with other departments and customers.Attend or facilitate conference calls and customer meetings to provide or obtain quality related information and customer specific metrics.Assist with populating quality related metrics and key performance indicators for team's performance.Assist with initiating and investigating quality deviations with the responsible functional area.Initiating and completing supplier non-conformance reports and effectuates material control.Assist with training, developing, and mentoring new Quality Coordinators.This position may require overtime and/or weekend work.Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Technical Writer/Group Lead of Technical Service department with 5 years of experience in pharmaceutical industry. Experience includes preparation/review and approval of Technical Service Documents, including standard operating procedures, master production/packaging batch records, investigation, deviations, validation protocols and reports, review draft document submissions and the associated change control for adherence to company policies and procedures. Pre-Development and Pharmaceutical Development Reports and Investigations. Training of staff for Technical Service documents as per the organizational requirements.

Document Reviewer experience includess manufacturing and packaging batch records, certificates of analysis, certificates of conformance, certificates of continued quality guarantee, etc. and daily production paperwork and identify product records that do not meet product release requirements.