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 Day (1st) shift. This shift schedule is Monday to 8:00 AM to 5:00 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
This position reports to Superintendent, Training. This role works very closely with the QC Lab Supervisors to develop a robust training plan for QC Lab personnel. The QC Lab Trainer is responsible for the delivery of a Lab New Employee Orientation training and hands-on training for core lab activities (e.g. xxx). Lead training effectiveness and improvement activities to support the QC Lab goals & objectives.
Essential duties and responsibilities:
• Maintain expertise in the areas in which incumbent is providing training.
• Prepare, deliver and maintain innovative and instructive training materials for QC core testing training program.
• Deliver the Lab New Employee Orientation training as needed
• Provide hands on training on core lab activities, methods/assays and instrument operation. Coordinate, schedule and conduct training as needed.
• Support the development and maintenance of the QC Laboratories training program
• Create and implement training materials that supplement associated assay CTPs and/or SOPs for assigned areas.
• Coordinate, schedule, and conduct Lab training, as necessary.
• Conduct periodic audit sessions for laboratory analysts evaluating compliance (including investigations), effectiveness of training, and comprehension of assays.
• Will be required to trouble-shoot lab procedures and processes and incorporate compliance, training, and mistake-proofing improvements.
• Create, revise, load, and route items per document change control requirements.
• Maintain updated revisions of SOPs and CTPs in accordance with periodic review requirements.
• Review, update, create, and assign training modules and curriculum to Laboratory personnel based on current practices or applicable changes in organization.
• Update and maintain Laboratory training matrices to identify training gaps and participation.
• Support development and execution of cross-training plans for assigned laboratory areas.
• Lead training effectiveness improvement projects
• Ensure compliance with Division and Corporate Lab general procedures.
• Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Ensure data integrity and regulatory compliance is maintained in assigned area and/or system.
• Ensure personal training requirements are met and that training records are current.
• Assist Supervisor in updating department metrics and reporting staff activities.
• Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.
• An independent thinker, highly motivated individual with great communication and patience to train effectively for the purpose of having all analysts perform testing in a standard, compliant manner each and every time
• Must demonstrate the ability to teach using adult learning techniques on assigned areas of knowledge. This may include the technical aspects surrounding theory and application.
• Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner.
• Solid organizational skills and ability to plan and suggest resolutions to technical or resource problems.
• Proficient in advanced aseptic techniques and microbial applications and/or wet/ instrumental methods of analyses is recommended. Demonstrated technical knowledge and experience in assays/equipment in functional area.
• Computer literate and proficient of word processing and spreadsheets (such as Microsoft Office).
• Proficient with lab application software.
• Must be very detail-oriented, conscientious, and responsible.
• Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
• Strong interpersonal communication and influencing skills. Must have good verbal and written communication skills. Must have effective presentation skills.
• Demonstrate effectiveness in training and coaching people with technical, compliance, or operational expertise.
• Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs. Familiarity with cGMP audit process, exception management, quality systems, and interpretation of regulations and quality systems.
• Demonstration of basic project management skills.
• Expertise in applying LEAN or Six Sigma principles & methodology is a plus.
• Must be able to learn new computer systems and programs in a timely manner.
• Must demonstrate proactive behavior.
Education and/or Experience:
Bachelor's degree in Science such as Microbiology, Biochemistry, Chemistry, or another science with Laboratory coursework with 5+ years of relevant experience.
-- or -
Master's Degree in Microbiology, Biochemistry, Chemistry, or another science with Laboratory coursework with 2 to 4 years of relevant experience.
• Must be able to lift, push, pull and carry up to 25 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
• 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.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required (APPLICABLE TO SNE only).
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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.