Shire Sr. Quality Control Analyst (3rd Shift) 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.

Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities, etc.

  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

  • Complete all testing, including special project / protocol testing in a timely and appropriate manner.

  • Initiate and obtain applicable approval for test requests

  • May maintain inventory/supplies necessary to conduct routine testing

  • Follow continuous improvement practices (QLP, 5S, LEAN, etc.)

  • Performs equipment maintenance and calibrations as required.

  • May serve as mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.

  • Writes exception documents.

  • Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

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

  • May perform other duties as assigned.

Requirements:

  • Proficient in wet and instrumental methods of analyses.

  • Advanced laboratory skills and basic knowledge of statistical method.

  • Strong technical problem solving skills

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

  • Must communicate effectively (verbal and written) with supervisors and peers.

  • Must demonstrate effectiveness in ability to train others

  • Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment

  • Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.

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

  • Knowledge of basic chemical and biological safety procedures.

  • Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.

Qualifications:

Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.

Appropriate additional certifications may be required pursuant to state or federal regulatory requirements

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, gender identity, 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.