Shire Laboratory Supervisor in Social Circle, Georgia

The Quality Laboratory Operations Supervisor is responsible for the operation of their laboratory area in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Shire BioLife policies, procedures and quality initiatives.

  • Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area.

  • Functions as supervisor for testing personnel performing high and moderate complexity testing. Organize and prioritize workloads and assignments in conjunction with donor center requirements.

  • Responsible for maintaining reagent and consumable inventory.

  • Performs annual employee performance reviews and employee counseling. Performs and reviews pre-analytical staff training and competency assessments. Ensures proper training is received under oversight of Operations Manager and CLIA Laboratory Director.

  • Performs NCMR, ENC and CAPA functions.

  • Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance. Participates in the evaluation of new tests and methodologies.

  • Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance. Participates in the evaluation of new tests and methodologies.

  • Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems.

  • Ensures periodic review of SOPs is performed and changes are implemented in a timely manner. Ensures that all procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines.

  • Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals.

  • Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality standards, efficiency, and schedules are met

  • Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor.

Minimum Degree Required: Bachelor’s degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,) and at least 3 years of laboratory training or experience.

OR

Associate’s degree in a laboratory science or medical laboratory technology, and at least 5 years of laboratory training or experience.

Certificate(s):

  • MT or MLT certification from ASCP or other accredited certifying organization preferred

Experience:

  • Previous supervisory experience in a laboratory setting preferred

KNOWLEDGE, SKILLS AND ABILITY:

  • Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.

  • Demonstrate work history of above average performance and attendance.

  • Excellent interpersonal skills and communication skills including written, verbal and oral presentations.

  • Result oriented with ability to adapt to changing priorities.

  • Attention to detail and organizational skills with analytical and problem solving skills.

  • Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.

  • Ability of Walking, standing, observing others performing work assignments.

  • Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.

  • Occupational exposure to blood borne pathogens.

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

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.