Sr Quality Assurance Specialist

Takeda Pharmaceutical Company • Social Circle, GA

86d • $86,500 - $135,960

About The Position

The position is responsible for Quality oversight of both the Packaging and Visual Inspection Operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with Manufacturing, Engineering, Maintenance, and Manufacturing Sciences teams.

Requirements

• Associates degree in business/scientific discipline and one to three years of relevant experience preferred.
• Bachelor's degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.

Responsibilities

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and support development and review of Protocols, Qualification, Regulatory Submissions, etc.
• Perform ongoing daily departmental activities related to deviation management and aid any issues tied to product disposition, including timely batch record reviews to ensure on time release of batches.
• Develop plans to correct identified risks including areas of non-conformance and approve and devise strategy to implement effective CAPA's.
• Responsible for technical review and approval of Non-Conformance investigations including deviations and Change Control records.
• Support Customer Complaint investigations with inspection of retention samples and returned product.
• Process the closure of Non-Product lot related investigations, extension requests and commitment records in the Trackwise database.
• Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Quality requirements.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical, and supervisory skills.
• Support manufacturing operations in lieu of absent personnel by maintaining all required qualifications.
• Lead ongoing, daily departmental operations.
• Evaluate, train and develop VI & Packaging QA team.
• Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections, Batch Record review- meeting requirements of CFR 21.
• Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.).
• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on packaging compliance.
• Other duties, tasks, or projects as assigned.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree