As a Quality Assurance Specialist II/III you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
*** Please note this position's working schedule is Tuesday – Saturday 10pm to 8:30am*** Main Responsibilities: Reads, understands, and follows SOP's and complies with cGMP's Writes new standard operating procedures or revises existing documentation utilizing document management systems. Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents. Supports the issuance and reconciliation of GMP documentation Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP. Reviews documented information from their functional area, reports abnormalities Assists in the implementation of new processes. Assists supervisor by assembling metrics as requested for their functional area. Provides task-oriented training to Specialists. Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items. Represents QA on site committees such as SHE, etc. Proposes and implements process and other efficiencies as approved by supervisor. Identifies process improvements in their functional area Coordinate's implementation of new processes in their functional area. Prioritizes day-to-day support for their functional area and longer-term projects or investigations Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to their functional area. Creates/revises QA documents (gap assessments, risk assessments, reports) in document management system Creates, owns, and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS Supports internal audits for documentation management, labelling, and/or quality systems with SOPs and regulatory requirements per the requirements of the self-inspection program Facilitates and coordinates training of new and existing team members, prepares training materials as necessary. Represents QA, as needed, during meetings relevant to their functional area, communicates, tracks all follow-up items through to completion Provides guidance to lower-level associates on a daily basis Minimum Requirement QA Specialist II Bachelor's degree in biology, engineering, or science-related field preferred 2-4yrs industry experience 2yrs QA experience preferred Minimum Requirement QA Specialist III Bachelor's degree in biology, engineering, or science-related field preferred 3-5yrs industry experience 4yrs QA experience preferred
