· Job facts
The suitable candidate works under general supervision to perform Quality Control PCR-based testing of bulks, components and finished kits for replenishment and stability monitoring purposes using established procedures and technical and theoretical understanding.
We are seeking a self-motivated analyst who can work well independently as well as in a team environment. Ability to interact with other analysts in the laboratory is essential. The work day is eight and a half hours long (for example 8:30 AM to 5:00 PM) however we occasionally require longer work days and weekends to meet testing requirements so flexibility is important.
· Sample collection, samples handling and maintenance of testing materials
· Assumes responsibility for the accuracy, quality and timeliness of results
· Analyzes data using various data analysis software and/or applying quantitative methods
· Summarize experimental results in tabular and graphic form when appropriate
· Data entry and analysis, validation of data and evaluation of trends
· Awareness and adherence to cGMP, GLP, other regulations
· Performs tasks according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g. OSHA)
· Participates in routine lab maintenance, routine cleaning, instrument maintenance, lab safety
· Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department.
· Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks.
· Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
· Duties may include handling of hazardous materials in activities described above. Depending upon area of assignment or primary focus, may maintain departmental stock rooms, keep labs stocked, prepare buffers as needed/required which may also include performing direct production or testing activities.
· Maintain stock rooms and laboratories or work areas properly stocked with daily supplies to include the scheduling of repairs and preventative maintenance as necessary and report malfunctions to supervisor.
· Monitor lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
· Duties may include handling of hazardous materials as described above. Depending upon area of assignment or primary focus, may perform various manufacturing and testing duties in addition to maintaining departmental stock rooms, log books, preparing buffers as needed/required which may also include, performing direct manufacturing activities such as bulk formulation, filling, sub-assembly and sample testing.
· Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform to established practices.
· Attends required training classes and participates in on-the-job training.
· Manages schedules, workload and establishes priorities using inputs from business requirements, SAP, and/or internal customer needs.
· Required: Associates Degree And 0-2 years general Laboratory Experience. Basic GMP Knowledge.
· Preferred: Bachelor or Associates Degree (Biology or Chemistry or Related Fields) with knowledge of PCR theory; academic laboratory experience preferable.
· Equivalent Combination of education and work experience acceptable.
· Knowledge of general laboratory practices and past experience with basic lab equipment such as pipettes and thermal cyclers is required.
· Hands-on work experience with Polymerase Chain Reaction (PCR) technology as well as experience gel-based assays is highly desirable.
· Working experience with a GMP/GLP Laboratory environment is highly desirable.
· Knowledge of computers/data entry is important. (Microsoft Word and Excel).
Demonstrates ability to follow Standard Operating Procedures (SOP) and Directions for Testing (DFT) documents. Demonstrates competence in reading and completing charts, forms, and other documents. Ability to use personal computer with basic word-processing and spreadsheet applications. Good written and verbal communication skills highly desirable.
· Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.