Quality Specialist - II (Associate) (100% remote)
Job description
On-Board Services is hiring a Quality Specialist II in West Point, PA (100% remote)!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Quality Specialist II
Job Location: West Point, PA (100% remote)
Compensation: $48.50
Length of Assignment: 1 year with a possibility of extension
Requirements:
- Individual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual documents and/or ensuring robust business systems in compliance with Company policies.
- The incumbent will be part of the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA. The incumbent will also drive and/or participate in cross functional initiatives to develop and optimize Quality systems and business processes.
- The incumbent will be responsible for supporting the development, maintenance, and enhancement of critical processes and systems.
Primary activities include, but are not limited to:
- Ensures that the organization operates within established policies/procedures of the Division and follows all established procedures within MSD.
- Maintains and provides expertise on ExN systems, tools, data, and processes on an ongoing basis. Executes actions for development, implementation, maintenance, and enhancement of systems including COMET SAP, Supplier Transparency, Ariba, IPI, and Collaboration sites.
Ø Supports ExN with Quality master data builds for new materials introduced through technology transfer and updates existing Quality master data to align and support batch release.
Ø Supports ExN with creation/updating of Supplier Profiles/Supply Chains in Supplier Transparency system. Responsible for executing periodic verification and resolving any discrepancy issues.
Ø Supports ExN with Ariba implementation at External Entity specifically as it relates to all aspects of the Quality Module.
Ø Provides ongoing systems SME support ensuring ExN data and processes run smoothly with no interruption to supply.
Ø Monitors reports of system issues and supports ExN for troubleshooting issues for SAP, Supplier Transparency, and Ariba systems.
Ø Supports EQA as SAP role approver for QM roles and supports issues related to identifying the right role in SAP. o Collaborates with IT and digital enablement team and represents Quality function within the Virtual Supply Chain team.
Qualifications:
- Minimum four-year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Chemistry, Chemical Engineering or equivalent preferred).
- Minimum of 3-5 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of COMET SAP material master data build experience, Quality Systems and Quality Assurance including solid knowledge of global GMP and regulatory requirements.
- Minimum 1 year experience in COMET SAP business workflow via T-Codes and/or reporting.
- Excellent analytical and computer skills, including software packages used in the maintenance and analysis of data is required.
- Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. Communicates in English, both verbally and in writing.
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 22-04701
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