Quality Assurance Specialist II
2 weeks ago
We are seeking a highly skilled Quality Assurance Specialist II to provide quality support and oversight to our Filling Operations team. As a key member of our quality team, you will be responsible for identifying and assessing regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and quality practices.
Key Responsibilities:- Lead ongoing daily departmental operations, including batch record review and floor auditing.
- Provide on-the-floor support to filling activities in an ISO 8 environment, overseeing aseptic techniques performed by manufacturing inside and outside of the filling isolator.
- Work with other personnel to achieve defined quality goals and perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
- Determine the logic, adequacy, and effectiveness of processes and related requirements and develop plans to correct identified risks, including areas of non-conformance, inform management, and implement approved corrective action plans.
- Write and analyze written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant Regulatory Requirements.
- Support external audits and assist with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions).
- Be a Subject Matter Expert (SME) and provide training to local employees on relevant areas and perform other tasks or projects as assigned.
- Bachelor's degree in the life sciences, engineering, or other related technical field.
- Three (3) years of experience in the biopharmaceutical industry.
- Must be a team player with good problem-solving skills and communicate well.
- Can guide decisions based on regulatory knowledge.
- Must have the ability to manage people, encourage teamwork, and lead decisions.
- Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Must have knowledge of Microsoft Word, Excel, and PowerPoint, TrackWise, Delta V.
- Must demonstrate understanding of complex manufacturing processes and make risk-based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.
- Decision-making and problem-solving include escalation of alerts and triages for on-the-floor deviations.
- Work with manufacturing, engineering, and quality systems group as primary job responsibility.
- Can work swing shift, some weekends, and holidays to support manufacturing.
At Takeda Pharmaceutical, we offer a competitive salary range of $67,000 to $106,700, depending on qualifications and experience. We also offer a comprehensive benefits package, including 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.
Equal Employment Opportunity:Takeda Pharmaceutical is proud to be an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws.
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Quality Assurance Specialist II
2 weeks ago
Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist II to join our team at Takeda Pharmaceutical. As a key member of our quality team, you will be responsible for providing quality support and oversight to our filling operations, identifying and assessing regulatory and quality risks, and ensuring compliance with regulatory agency...
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Quality Assurance Specialist II
2 weeks ago
Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the Role:We are seeking a highly skilled Quality Assurance Specialist II to join our team at Takeda Pharmaceutical. As a key member of our Quality Assurance department, you will be responsible for providing quality support and oversight to our Filling Operations team.Key Responsibilities:Regulatory Compliance: Identify and assess regulatory and quality...
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