Quality Specialist

System One; Indianapolis (IN); On-site; Full time

Job summary

A leading pharmaceutical company seeks a Quality Specialist for an 18-month contract in Indianapolis, IN. The role includes quality control responsibilities, requiring at least 5 years of QA experience and an associate's degree. Ideal candidates will have strong skills in change management and MS Office, along with the ability to communicate and solve problems effectively.

Benefits

Health and welfare benefits coverage options

Medical, dental, and vision insurance

401(k) plan participation

Qualifications

• At least 5 years of experience at a manufacturing site within QA.
• Excellent knowledge in manufacturing operations, quality and supplier quality management preferred.
• Strong interpersonal and oral presentation skills.

Responsibilities

• Execute supplier quality management processes in compliance with Global Quality Standards.
• Collaborate with manufacturing/affiliate sites to ensure robust and effective process execution.
• Support maintenance of supplier quality management data.

Skills

Change Management

MS Office Suite

Communication

Problem Solving

Education

Associate's degree or other advanced education or training

Tools

SAP

TrackWise

Veeva QualityDocs

PowerApps

PowerBI

Tableau

Job description

Job Title: Quality Specialist
Location: Indianapolis, IN
Work Schedule: Mon - Fri, 8am - 5pm
Pay Range: $30 - $34.85/hr
Type: 18-month contract, Potential for extension or conversion to permanent

Overview
Leading pharmaceutical company looking for an experienced Quality Control Representative. Ideal candidates should have at least5 years of experience at a manufacturing site within QA organization. Required skills includeexperience 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 Lilly 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.

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