Quality Systems, ERP
Minnetonka, MN
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Pay:$63-68/ph
Job Responsibilities:
In this role, you will support our biotech client's Quality department with a focus on the implementation and optimization of Quality processes within an Enterprise Resource Planning (ERP) system. Additional responsibilities include supporting product release documentation, internal manufacturing operations, and managing equipment calibration and qualification programs.
Key responsibilities include:
- Designing, building, and validating Quality-related ERP processes.
- Creating, editing, and proofreading standard operating procedures and work instructions.
- Training end users on ERP-related Quality functions.
- Supporting GMP production through the issuance and review of batch records.
- Compiling documentation for product release and managing submissions in the electronic Quality Management System (eQMS).
- Administering and issuing logbooks.
- Scheduling and tracking calibration activities, and supporting equipment qualification.
- Collaborating cross-functionally to ensure compliance and support product quality.
- Performing other duties as assigned.
Essential Duties and Job Functions:
- Participate in ERP process development, testing, and deployment from a Quality perspective.
- Ensure documentation aligns with regulatory standards and internal requirements.
- Conduct training sessions for ERP Quality process users.
- Issue and review GMP documentation, including lot number assignments and expiration calculations.
- Manage product release records, including data entry in the eQMS and shipment approvals.
- Coordinate calibration scheduling and interface with teams during equipment qualification.
- Support compliance efforts across departments, focusing on patient safety and product integrity.
- Communicate effectively with internal teams and stakeholders.
Knowledge & Skills:
- Expertise as an ERP super-user, preferably with NetSuite.
- Strong understanding of GXP and regulatory requirements.
- Skilled in documentation control and quality process development.
- Strong communication and interpersonal skills.
- Ability to work independently and collaboratively.
- Knowledge of equipment and calibration systems in GMP settings.
- Critical thinking and sound decision-making under pressure.
- Familiarity with combination products, medical devices, or aseptically produced pharmaceuticals preferred.
Education & Experience:
- Minimum of 5 years of experience in the life sciences industry.
- Broad Quality Assurance experience in manufacturing or operations.
- Experience in small- to mid-sized organizations, including vertically integrated or virtual structures.
- Technical knowledge of equipment and software relevant to ERP and Quality systems.
Travel:
- Up to 5% travel may be required.
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