Quality Assurance Specialist II at Baxalta U.S., Inc. in Social Circle, Georgia

Job Description:

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Job Description

About the role:

You will provide Quality support and oversight with direct staff management or process/area responsibilities. You will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and our quality practices. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, and Laboratory Operations. You will report directly to the Supervisor, Quality Assurance.

How you will contribute:

• Lead ongoing, daily departmental operations.


• May include the management of assigned personnel in achieving defined quality goal. You may Interview/hire and develop direct reports.


• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes and system related requirements.


• Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.


• Revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements.


• Navigate, answer alerts and review Batch Records in EBM.


• Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.


• Support external audits.


• Help with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions.


• You are a support function to manufacturing operations and is required to coordinate testing activities and communication of results with IG, Fractionation, and Albumin. You will also correspond with other departments such as QA, Engineering, Maintenance. You may be asked to participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.

• Typically requires bachelor's degree in science, engineering or other related technical field.


• 3+ years of related experience.


• Proficient in wet and instrumental methods of analyses.


• Advanced laboratory skills and basic knowledge of statistical method.


• Technical problem-solving skills.


• Effectiveness in ability to train others.


• Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.


• Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurements.


• Knowledge of basic chemical and biological safety procedures.


• Knowledge of Microsoft Excel (can perform complex functions).

• Comprehensive Healthcare: Medical, Dental, and Vision


• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan


• Health & Wellness programs including onsite flu shots and health screenings


• Generous time off for vacation and the option to purchase additional vacation days


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional training and development opportunities


• Tuition reimbursement

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.


• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.


• Work in a cold, wet environment.


• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.


• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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EEO Statement

Takeda is proud in its commitment 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, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time