Shire Lead Quality Associate in Social Circle, Georgia

Performs a variety of chemical, biological, or physical analyses on quality control samples in support of the company’s quality program. Works as part of the site quality control function, focusing on method and testing process improvements. Serves as local QC representative for cross-functional and inter-facility projects. Trains and leads others within the laboratory.

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

  • Performs and reviews advanced biological and chemical assays

  • Maintains knowledge of instrument, software, and documentation for repair and calibration of instrument systems

  • Provides training and work direction and serves as a mentor to other Quality Laboratory Associate positions

  • Conducts method remediation/improvements and serves as method introduction representative for local QC

  • Works to bring best practices to the site (e.g. securing controls, implementing testing and maintenance strategies, etc).

  • Leads corporate and regulatory audits as required

  • Completes corrective actions from audits, non-conformances, LIRs, etc.

  • Works on special projects involving new methods and instrumentation including validations, feasibility studies, and development work

  • Keeps up to date on industry standards for QC testing

  • Reviews method development protocols and summary reports

  • Leads and participates in continuous improvement initiatives, using DMAIC/Blue Belt principles to generate solutions for QC issues

  • Interfaces with functional representatives at the site level (Production, Tech Ops, etc) as part of production problem solving teams

  • Prepares, reviews and revises, as required, protocols, SOPs and CTPs.

  • Recommends instrument purchases and upgrades for the laboratory that ensures optimum lab performance.

  • Troubleshoots and resolves instrument problems

  • Writes Level I and Level II non-conformance reports, laboratory investigation reports, and control chart investigation reports as needed

Strong team player and willingness to help others when needed. Communicates effectively in both written and verbal modes. Openly shares information, listens to and values feedback, shares opinions and feedback directly. Strong leadership, organizational, and time management skills. Demonstrated effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion. Decision making and technical problem solving abilities. Ability to lead projects with minimal supervision. Strong computer skills and organizational skills.

BS in Chemistry, Biochemistry, or related field with a minimum of 10 years pharmaceutical laboratory experience or a Masters in Science degree in Chemistry or Biochemistry, with 5-8 years of experience.

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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.