Quality Associate II – QA Ops

Takeda • Round Lake, IL

1d • Onsite

About The Position

As a Quality Associate II at the Takeda Round Lake aseptic pharmaceutical manufacturing facility, you will work to perform review and approval of released raw material documentation. You will focus on product quality and compliance through Documentation review (Batch records, electronic batch records, etc.), Investigation/Change control approvals and Quality oversight of manufacturing processes.

Requirements

• Typically requires bachelor's degree, preferably in science, engineering, or other related technical field.
• 2+ years of related work experience
• Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.
• Must have knowledge of FDA Regulations and Application of Good Manufacturing Practice.
• Must demonstrate strong leadership, influence, and cross-functional collaboration skills and be able to work efficiently in a cross-functional team environment.
• Ability to prioritize and thrive in a fast-paced environment.
• Strong interpersonal skills and attention to detail.
• Must be a team player with excellent problem-solving, critical thinking, and decision-making skills.
• Highly effective verbal and written communication skills.
• Must be able to manage multiple projects concurrently.
• Excellent Microsoft Office skills (Word, Excel, Project, and PowerPoint).

Responsibilities

• Responsible for raw material and bulk container receipts, release, and investigation if any issues are found.
• Follow-up with appropriate Takeda facilities for documentation correction in timely manner.
• Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card management, management and delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management
• Back up for the site Stability Program and ensure adequate monitoring of stability sample shipment, testing, and stability protocol approval.
• Coordinates with Global Stability on any process changes, and responsible for communication and implementation of changes locally.
• Owns Standard Operating Procedures and other Quality Documentation relevant to Quality department.
• Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant.
• Develops and delivers training materials relevant to Quality operations.
• Approves training materials pertinent to all areas of the plant.
• Owns investigations and CAPAs relevant to area of expertise.
• Approves investigations and CAPAs pertinent to all areas of the plant.
• Approves change controls for compliance to existing requirements.
• Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
• Leads Quality project teams and presents to plant management project plans, progress, and risks.
• Represents the organization to governmental regulatory bodies.
• Review/approve and investigate any JDE inventory management system discrepancies and reach out to appropriate teams to resolve the issues.
• Utilization of electronic systems such as TrackWise, JDEdwards, and EBM/C3ME.
• Participate in internal and external regulatory audits as an SME for Quality operations and present to auditor, if required.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees