Quality Assurance Specialist Ii/Iii -- Remote

As a Quality Assurance Specialist II/IIIyou’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