ERP Quality Systems Specialist

Manpower Engineering is partnering with a leader in the Pharmaceutical industry for a Quality Systems Specialist - ERP.

Job Title: Quality Systems Specialist - ERP
Location: Minnetonka, MN (HYBRID)
Pay: $50 - $68/hour
Duration: 12 month contract

POSITION SUMMARY:

Day-to-day responsibilities are primarily focused on the implementation of quality processes within a new Enterprise Resource Planning (ERP)system. This role will also be involved in the reviewing and compiling of documentation for finished product releases, supporting internal manufacturing by performing quality assurance tasks, and managing the equipment and calibration programs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Participate in the design, building, and validation of Quality processes within the ERP system.
• Writing, editing, and proofreading work instructions and procedures to support ERP implementation
• Train end users on how to execute their functions within the ERP.
• Issue internal batch records for GMP production. Prepare and review lot number and expiration date calculations and ensure compliance of batch records with GXP requirements.
• Compile product release records into the eQMS system, issue product shipment authorizations.
• Maintain and issue logbooks.
• Schedule calibration activities, support equipment qualification processes, and interface with cross-functional teams to ensure compliance to equipment administration program.
• Collaborate with other departments to maintain compliance and ensure product quality and patient safety.

• Communicate effectively with all groups

• Super-user ERP experience with an ERP system, preferable NetSuite.
• Minimum 5 years of experience the life science industry.
• The candidate will possess broad experience within the Quality function.
• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
• Strong background in a manufacturing and operations environment preferably supporting drug-device combination products, medical devices, and/or aseptically-produced pharmaceutical products.
• Experience working within vertically integrated and virtually-structured settings for small- to mid-sized organizations is preferred.
• Technical, equipment, software knowledge necessary

Benefits:
Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long-Term Disability Insurance
• Accrued Sick Pay
• 401(k)