Shire Principal Quality Laboratory Associate 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.

Job Title:

Principal Quality Laboratory Associate (Sr Quality Assurance Specialist II)

JobCode:

11544

Function:

Quality

Supervisor's Title:

Supervisor, Lab Support

FLSA:

Exempt

Summary:

This section focuses on the main purpose of the job in one to four sentences.

Provide SME support for activities in and around the Quality Laboratory Instrumentation and Administration group. Responsible for technical support of LIMS and related projects.

Essential Duties and Responsibilities:

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.

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

  • Execute the administration of certain laboratory systems including LIMS, Empower, and all instrument-specific or enterprise systems.

  • Ensure laboratory system support of all manufacturing processes.

  • Ensure completion of all protocols and validations in a timely and appropriate manner.

  • Participate in global initiatives with cross-functional teams as required.

  • Ensure compliance with system testing SOPs and specifications.

  • Assure compliance with company procedures, applicable quality and regulatory requirements and guidance including cGMP and USP rules. Compliance will keep the department ready for an audit by both internal and external authorities. It is the responsibility of the Principal Quality Laboratory Associate to answer technical questions concerning the department posed by any inspector.

  • Prepare, review and revise, as required, SOPs and specifications.

  • Perform other duties as requested by leadership.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Must know operating and troubleshooting procedures for lab equipment software and lab enterprise software systems including LIMS and Empower. Must know government regulations pertaining to pharmaceutical and medical device manufacturing labs. Must be able to lead projects with good knowledge of lab testing processes and technical problem solving skills. Must be able to effectively communicate with peers and managers.

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

Bachelors Degree in Chemistry, or biological science with 5-8 years of experience in pharmaceutical production. Fifteen+ years of lab system administration experience required.

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.