System One

Job Title: Quality Control Representative

Location: Indianapolis, IN

Work schedule: Monday- Fri 8am- 5pm

Type: Contract

Overview

Leading pharmaceutical company looking for an experienced Quality Control Representative. Ideal candidates should have at least 5 years of experience at manufacturing site within QA organization. Required skills include experience in change management and MS office Suite (Teams, OneNote, OneDrive, SharePoint, PowerPoint and Excel).

Requirements

Education:

• Associate’s degree or other advanced education or training

Experience:

• Excellent knowledge in manufacturing operations, quality, and supplier quality management is preferred.
• Experienced in SAP, TrackWise, and Veeva QualityDocs is preferred.
• Experienced in Change Management.
• High ability in execution of MS Office basic suite (Teams, OneNote, OneDrive, Sharepoint, PowerPoint, Excel).
• Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent interpersonal and oral presentation skills…. as well as strong written communication skills.
• Creativity in strategy development and problem solving.
• Ability to work independently and as part of a team with minimal supervision.
• Ability to communicate, convince, train.

Additional Skills/Preferences includes:

• Five (5) years of minimum experience at manufacturing site within QA organization
• Good knowledge of quality management; Supplier Quality Management; ISO and GMPs
• PowerApps, PowerBI, Tableau experience
• Knowledge of GQS, CQP, LQP

Responsibilities

• Execute supplier quality management process in compliance with Global Quality Standards (GQS305, GQS301 & GQS307) in addition to others, as applicable
• Assist procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing functions in identifying and managing material suppliers and GMP Service Providers.
• Execute SAP and TW138 activities in the approved supplier list (ASL) process of suppliers and/or GMP service providers for site expansions on behalf of the sites. Collaborate with SAP Business QA as needed.
• Collaborate and communicate with manufacturing/affiliate sites across the networks (API / Manufacturing / Packaging / DPEM / APIEM / Devices) to ensure process execution is robust and effective and barriers are escalated.
• Develop and communicate processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives.
• Provide support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, VeevaVault (QDocs), TrackWise.
• Support execution of Certification Package Review Board and global certification packages for global SAP Manufacturing Plants (MPs) materials.
• Partner with Global TS/MS to develop and execute the material risk control strategy (material risk, product acceptance risk, specification controls).
• Provide input and support for supplier related change controls.

This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Personal Development

• Be continually aware of current industry trends and regulatory agency interpretation of GMP/cGMP and other relevant requirements, in particular, those related to the Supplier Management Programs.
• Maintain good interpersonal and communication skills with business areas with emphasis on verbal and technical writing skills.
• Complete required training and qualifications for the roles identified in the Learning Plan (LP).

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.