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.
This position reports to Weekend Grave (E) shift. This shift schedule is Friday and Saturday 6:00 PM to 6:00 AM, plus a third shift during the week. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Responsible for coordination (pick-up, receipt, aliquoting, distribution and shipping) of in-coming bulk, intermediate, final containers, final package, stability and validation samples. Perform data entry and data collection. Perform daily lab support operation activities (e.g. material and supply inventory/ replenishment, kitting, dishwashing, autoclaving, biohazardous trash removal and QC Documentation Control) to ensure QC Labs have samples, materials, QC documentation available to meet operational testing turnaround times using Lean Principles. Emphasis on continuous improvement and cost effectiveness in daily activities. Participate and/or drive completion of responsible tasks and improvement projects. Must have very strong communication, customer service skills and demonstrate excellent teamwork.
Essential duties and responsibilities:
• Pickup, receive, aliquot, and distribute samples to the appropriate laboratories for testing using GMP/ GDP/ LIMS.
• Support in troubleshooting of issues as they arise from sample and documentation management and investigate deviations.
• Perform lab support activities such as supplies replenishing and ordering of supplies/ services, inventory, kitting, dishwashing, operating depyrogenation oven, autoclaving, and lab wastes removal.
• Ship samples to external laboratories for testing in a timely and accurate manner.
• Perform data collection/ data entry for external laboratory testing or as assigned for continuous improvement activities.
• Perform review of test data with application of GOP.
• Use Global LIMS or other computerized systems for sample receipt, and entering/ approving test results, where assigned.
• Responsible for laboratory documentation including the creation, issuance, and archiving of test data packets, test requests, and other QC related documentation.
• Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Ensure laboratory area is maintained in a GMP state at all times while following all EHS and Lean guidelines. Perform laboratory GEMBA walkthroughs to ensure area is suitable for hand off to oncoming shifts.
• Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner.
• Will be required to generate, review, and make revisions to procedures and laboratory documentation.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
• May provide training for assigned functional areas as required.
• Drive Lean principles such as Just in Time Supply replenishment and 5S throughout daily work activities.
• Ensure personal training requirements are met and that training records are current.
• Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner with minimal supervision.
• Must demonstrate ability for taking on additional assignments, driving continuous improvement to meet quality compliance, operation excellence, and cost effective initiatives.
• Good teamwork, communication to both internal and external customers, organizational and time-management skills demonstrating ability to manage multiple projects and/or operations concurrently and effectively.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems related to Lab Support activities.
• Demonstrated working knowledge of equipment in functional area.
• Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office) as well as other computerized systems (LIMS, JDE, Coupa, etc).
• Must be detail-oriented, conscientious, and responsible.
• Capable of applying some decisions-making to problem-solve sample integrity issues, compliance, or operational problems as assigned.
• Effective interpersonal communication. Must have effective verbal and written communication skills.
• Good project management skills a plus.
Education and/or Experience:
• High School diploma or equivalent, AA Degree preferred, plus 2-4 years' experience in related field.
• Must be able to lift, push, pull and carry up to 25 lbs.
• 20/20 near vision required (corrected is acceptable).
• In general, the position requires a combination of walking to pick up samples from various sample collection locations in manufacturing throughout the day as well as performing inventory, stocking, dishwashing, autoclaving etc. of laboratory materials. There may be some sedentary work as assigned.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Required to work with biohazardous or hazardous waste removal/transferring.
• May be required to work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required.
• May be required to work in a confined area.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.