QA Specialist Ii/iii

3 weeks ago

Chicago, United States Locks Global Staffing LLC Full time

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

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