Quality Assurance Representative

MD Logistics Inc•Plainfield, IN

7d•$48,000 - $53,000•Onsite

About The Position

The QA Representative (QA Rep) is the front line of quality for site operations. The QA Rep is involved in daily operations and decision making, working with the area operational staff to assure that operations comply with local standards, and products/services meet established quality criteria.

Requirements

High School Diploma or GED Equivalent required.
One year of experience in a quality function, or 2 years experience in a quality systems environment, preferably in the pharmaceutical or supporting industries.
Must be very detailed oriented.
Proficiency with Microsoft® Outlook, Word, Excel, and familiarity with warehouse management systems.
Ability to read, write, and interpret documents such as safety rules, operating and maintenance instructions, and correspondence.
Ability to express concepts and thoughts in writing.
Ability to respond to common inquiries or complaints form customers, regulatory agencies, or members of the business community.
Ability to conduct training.
Ability to speak effectively in front of groups, before customers or correspond via email.
Ability to physically count, add, subtract, multiply and divide.
Understanding of fundamental statistics.
Ability to define problems establishes facts and draw valid conclusions.
Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
Must be able to discern color.

Nice To Haves

Some college preferred.

Responsibilities

Monitor daily operations activities, communicate, and escalate issues appropriately
Provide operations with product disposition, line clearance, and any other actions needed to facilitate daily production
Conduct quality risk assessments of systems and controls
Check for adherence to written procedures through self-inspections and assessments
Periodic review of GMP-related data in the area
Develop, implement, monitor and modify Quality action items
Determine deviation level, ensure that investigations are complete, and that corrective and preventative actions are implemented
Provide review and approval of required quality documentation (e.g., deviations, change controls, validation/qualification packages, area or equipment operation procedures, and drawings)
Support client audits
Conduct internal audits
Participate in vendor, third party and GMP service provider audits
Evaluate process excursions for potential impact to product SISPQ
Write procedures, investigations, customer correspondence, and any other quality functions that require documentation
May be required to complete customer specific in-process sampling
Batch disposition
Participate on process or area teams
Align area Quality Plan action items with business objectives
Work collaboratively with customer quality units to resolve problems and develop opportunities
Understand the impact of quality processes on production/productivity
Participate on teams, committees or groups to achieve departmental, site or company goals
Attend industry or professional organization meetings
Maintain sound technical understanding of the area’s processes
As assigned by upper management.