Quality Systems Specialist - ERP - Torrance, CA | Biospace
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Quality Systems Specialist - ERP

Bachem

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Location:
Torrance, CA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality,

Job Description

The ERP Quality Systems Specialist will oversee the quality assurance aspects of implementing SAP at two manufacturing sites in the US. This Quality Assurance cross-functional role ensures that all relevant business processes in the US, which may have an impact on GMP compliance, meet the expected regulatory standards. This individual will work directly with the global SAP project team and local team members in the US to ensure quality relevant processes at the US sites are compliant with cGMP regulations. The incumbent is responsible to ensure GMP Operations’ deliverables for the US sites fall within the applicable timeline and scope. He/she is responsible for smooth implementation of end-to-end quality relevant processes.  This position will be responsible for managing US implementation of future phases of SAP that will be adding more functionality in the coming years from the GMP Operations’ standpoint. This position will work closely with all functional areas in the US that are involved with SAP implementation of quality relevant processes to ensure the hand-off between different areas is carried out properly. The incumbent will be responsible for approving Quality relevant SAP documents.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

•   Represents the US Quality Assurance Department in the global SAP project
•   Single point of contact for all US QA-related concerns
•   Provides regular updates to the project manager
•   Identifies and raises area specific bottlenecks and resource issues for the US sites
•   Participates in workshops, trainings and relevant project meetings
•   Evaluates impact of the SAP implementation on GMP relevant processes and resources and makes recommendations for optimal outcome to senior management
•   Ensures QA/QC deliverables for the US sites are completed within the global project timelines
•   Coordinates activities of QA and QC departments in the US to meet the global project demands
•   Coordinates and monitors document revisions at US sites to meet the project goal
•   Ensures end-to-end quality processes are compliant with US FDA and other regulatory agencies’ requirements
•   Establishes and manages communication channels with the global and local management team
•   Approves Quality relevant changes in material master data
•   Monitors the validation activities in the context of the new CSV guideline for software validations
•   Approves functional specifications and user requirement specifications
•   Approves computer system validation documents

Requirements

Required:

•   Bachelor’s Degree in Life Science or related fields
•   Minimum of 5 years’ experience in an FDA regulated industry: pharmaceutical, Medical Device, etc.
•   Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance
•   ERP (SAP preferred) Quality Management expertise in Master data (Inspection Plans, Sampling plans, QM Material master data), Inspection methods, Inspection types, results recording, usage decision, notifications, etc.
•   Good understanding of end- to- end quality relevant processes within an ERP system
•   Excellent understanding of ERP (prefer SAP) functionalities and process flows
•   At least 2 years of experience interacting within ERP: Logistic, Quality and Production Processes
•   Excellent written and oral communication skills
•   Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Access
•   Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
•   Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
•   Detail oriented with the ability to troubleshoot and resolve technical and analytical problems
•   Ability to work independently and manage one’s time
•   Communicate effectively and ability to function well in a team environment

Preferred:

•   Experience with SAP
•   ERP (prefer SAP) Material Management expertise includes purchasing, inventory management, configuration and creation – Material Master, Info record, Vendors, Stock Transport orders, Purchase requisitions, Customers, Contracts, and invoice verification
•   Knowledgeable in Incoming inspection, in process inspection and final inspection checks
•   Technical writing experience