Shire Quality Assurance Specialist II 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:

Execute and/or Lead Quality Control Compliance team activities to ensure the safety and reliability of Shire 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

  • Execute thorough investigations and complete 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 perform RCA and identify appropriate CAPAs.

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

  • Conduct investigative audits of manufacturing areas and/or personnel as required.

  • Perform investigative sampling of manufacturing areas as required.

  • Prepare and present trend analyses to management during routine operating mechanisms.

  • Support 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 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.

  • Work with minimal Supervision.

Requirements:

Advanced laboratory skills are preferred, basic knowledge of statistical methods.

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

Applies sound decision-making to problem-solve technical, compliance, or operational problems as assigned.

Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.

Possess solid understanding of manufacturing and facility processes.

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

Demonstrates solid communication skills (verbal and written) with management and peers and be able to work cross-functionally with other groups.

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

Solid presentation skills are required.

Qualifications:

Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 3+ years of related 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’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.