Shire Quality Assurance Specialist II (Weekend Shift) in Social Circle, Georgia

Execute and/or Lead Quality Control team activities to ensure the safety and reliability of Takeda products are in compliance with quality and regulatory requirements. Complete robust investigations that determine accurate root causes and effective corrective and preventive actions. Maintain effective application of operating mechanisms and quality systems. Execute tasks in support of Contamination Control Program (CCP) initiatives. 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.

Act as a Lead relative to investigations and problem solving, with focus on remediation and prevention of issues including microbial contamination

  • Conduct biological, chemical and physical analyses on raw materials, initial, in-process, and final products and samples collected from the environmental monitoring programs at Shire manufacturing facility.

  • Write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods

  • May serve as a mentor to other Quality Laboratory positions. Provide training and work direction for Laboratory technicians as required. Manage workflow and laboratory release functions in specified laboratory areas and on off shifts.

  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.

  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.

  • Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.

  • Work on special project/protocol testing that involves new methods and instrumentation. Complete all testing, including special project/protocol testing in a timely and appropriate manner.

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Investigate deviations and write exception documents.

  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

  • Perform laboratory and manufacturing audits as required. Audit and update, as required, SOPs.

  • Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.

  • Work with minimal Supervision.

Requirements:

  • Ability to handle multiple tasks concurrently, and in a timely fashion.

  • Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.

  • Ability to multi-task and set priorities for multiple projects. Ability to deliver high quality results within set timelines.

  • Strong leadership, organizational and time management skills, and ability to handle multiple tasks.

  • Must communicate effectively (verbally and written) with supervisors and peers and be able to work cross-functionally with other groups.

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Knowledge of chemical and biological safety procedures.

  • Strong computer skills, knowledge of Microsoft Word, Excel, and PowerPoint. Qualifications: Bachelor's degree in chemistry, biological science, or biological science with a minimum of 5 years of related experience or a Master’s Degree in Chemistry or biological science with 1-4 years’ experience.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.