Shire Senior Quality Assurance Specialist in Social Circle, Georgia

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Description:

Drive and/or Lead Quality Control Compliance team activities to ensure the safety and reliability of Shire products and compliance with quality and regulatory requirements. Ensure completion of robust investigations that determine accurate root causes and effective corrective and preventive actions. Maintain and continuously improve upon daily operations workflow to support effective application of operating mechanisms and quality systems. Coach personnel to improve and enhance their performance. Ensure completion of 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. Continuously drive the application of Lean and Six Sigma principles to the floor level through activities such as Rapid DMAIC problem solving and Kaizens.

  • Act as a technical resource relative to investigations and problem solving, with subject matter expertise focused on remediation and prevention of issues including microbial contamination

  • Drive execution of thorough investigations and completion of nonconformance events (e.g. Deviation, OOL, OOS, etc.) in an effective and timely manner and to meet product fulfillment dates.

  • Collaborate with other Quality, Manufacturing, and support departments to ensure execution of RCA and identification of appropriate CAPAs are performed.

  • Lead and/or support problem solving sessions through application of various problem solving tools and methods.

  • Assist in implementing quality and regulatory requirements and ensure compliance with testing SOPs and specifications.

  • Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

  • Drive Contamination Control Program (CCP) initiatives to mitigate and prevent risk to product.

  • Support internal and external laboratory audit readiness efforts

  • Mentor other Quality Laboratory positions and provide training and work direction for Quality Control positions as required.

  • Prepare, review, and revise, as required, documentation that supports proper functioning of lab operations (e.g. SOPs, investigation memos, technical documents, etc.)

  • Drive Lean principles such as 5S throughout daily work activities.

Requirements:

  • Able to assess current systems/processes including those Laboratory related and provide guidance, where needed.

  • Demonstrates strong technical writing skills (e.g. investigation reports) and the ability to seek and identify robust mistake proofing solutions.

  • Demonstrates solid critical thinking to identify potential and existing issues and provide solutions to those issues

  • Strong at ensuring compliance and GMP requirements as well as addressing customer concerns

  • Good leadership, organizational, and time-management skills demonstrating the ability to manage multiple projects and/or operations concurrently and effectively. Must be able to manage complex scenarios and continue to meet business commitments on time.

  • Proficient in utilization of Quality Systems such as TrackWise, LIMS, EBM, JDE, and PI.

  • Solid at handling and resolving conflicts (including personnel related) in a proactive manner.

  • Must demonstrate the ability to effectively coach, mentor and motivate personnel at different levels, resulting in a high-performing team with a focus on results and task completion in support of operational goals.

  • Must demonstrate effectiveness in supporting an environment of accountability for assigned tasks, work rules, and safety standards through a combination of positive and constructive reinforcement.

  • Must demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues

Qualifications:

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

  • 5+ years of related experience.

  • Some leadership experience preferred.

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire 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 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.