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Supervisor, Quality Assurance - Lab

Social Circle, Georgia


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Supervisor, Quality Assurance - Lab

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Job ID SR0054728 Date posted 09/28/2020 Location Social Circle, Georgia

Supervise Quality Control Compliance team activities to ensure the safety and reliability of Takeda products are in compliance with quality and regulatory requirements.  Interface routinely with Manufacturing, Quality Assurance, and Quality Systems to support product fulfillment and regulatory requirements.  Apply Lean and Six Sigma principles through participation in activities such as Rapid DMAIC problem solving and Kaizens.

• Ownership of all aspects of the Quality Control investigation process • Lead deviation investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by: • Lead problem solving and root-cause analysis sessions • Interact with Quality Assurance, Engineering, and Manufacturing Sciences • Manage complex investigations using DMAIC tools • Ensure effective implementation of corrective and preventive actions • Management of highly technical / visible investigations • Owner / point of contact for global initiatives / projects • Author and revise documentation that supports proper functioning of lab operations (e.g. CTP, SOP, Change Control, investigation memo, technical document, etc.) • Train staff in general Quality Control activities • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding / problem solving capability • Stay current with biopharmaceutical industry best practices and technologies • Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects Job Description 2 • Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns • Coordinates quarterly review meetings of quality data and trends to upper management • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations • Support internal and external laboratory audit readiness efforts • Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality • Conduct investigative audits of manufacturing areas and/or personnel as required • Support Contamination Control Program (CCP) initiatives to mitigate / prevent risk to product

Typically requires bachelor’s degree in science, engineering or other related technical field. 5+ years of related experience • Demonstrated ability to perform in a high performing workforce • Some leadership experience preferred

Able to follow directions • Able to identify when proper practices/ procedures are not performed • Follow SOPs and identify processes and results • Execute changes and corrections • Self-starting and task proficient • Escalate accordingly • Ensures timely communication of issues • Ensure appropriate communication between personnel, groups, and between departments • Coordinate activities, schedules staff, etc.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0054728

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