Ability to perform, verify, and give feedback on complex and involved services, procedures, and other general duties, independently, for a client base that may include Pre-Clinical, Process Development, Research, Manufacturing and Quality. Continues to maintain the ability and knowledge for routine functionality.
1.Begins to become trained in Level I&II GMPs/GLPs (if required).Read and train on area specific SOPs.
2.Conducts routine laboratory procedures such as performance of simple chemical, physical, and/or biological tests; and maintenance of related notes and records. Provides basic laboratory support functions including stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing glassware.
3.Learns to follow Site guidelines, policies, and procedures, including lab and plant regulations.Responsible for maintaining accurate documentation and records, including monthly and quarterly reports.Begins to work cross-functionally in all buildings.
4.Begins to demonstrate accountability for quality of product and services to minimize impact to functional areas.
5.Begins to interact with the clients for needs assessment.Possess basic computer operation skills.
6.Good comprehension and communication skills (both written and oral).Possess basic organizational and time management skills.
7.Prompt and regular attendance to on-site Amgen workplace.Fully trained in Level I & II GMPs/GLPs (if required.Shows proficiency on area specific SOPs and may serve as reviewer for logbooks.
8.Performs standard technical procedures such as preparing routine solutions and reagents and performing routine reactions.Under supervision, may analyze compounds.
9.Conducts general laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing glassware. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation.Performs and maintains timely and accurate documentation and records in lab and overall lab environment.
10.May assist in training LST I.May serve as designee for GMP equipment and areas and learns work order system (if required).Demonstrates a working knowledge of site guidelines, policies, and procedures, including lab and plant regulations.
11.Participates and contributes to group and project meetings.Works cross-functionally in all buildings (if required).
12.Performs problem resolution, including identifying problems and offering solutions. Demonstrates accountability for quality of product and services to minimize impact to functional areas.
13.Interacts with the clients for needs assessment. May assist with projects and communicate effectively to assess and utilize resources within the department.
14.Computer operation skills, including spreadsheet maintenance, to perform all technical and record keeping duties in requirements.
15.Prompt and regular attendance to on-site Amgen workplace.
16.Fully trained in Level I & II GMPs/GLPs, and may begin to train in Level III GMPs/GLPs(if required)
17.Shows proficiency on and evaluates area specific SOPs.
18.Performs a variety of routine and no routine laboratory procedures such as preparing more complex solutions and reactions and operating more complicated laboratory equipment.Makes and records observations and performs more advanced calculations of data to be used for evaluation.
19.May assist in special studies to analyze causes of atypical results. Laboratory support functions include setting up and dismantling instruments and apparatus. Basic Qualifications Associate’s degree & 4 years of directly related experience
High school diploma / GED & 6 years of directly related experience. Preferred Qualifications Additional Functions:
1.As required, uses personal computer to perform technical and record-keeping duties in conformance with company and regulatory policies to meet quality and accuracy requirements.
2.May oversee and approve all work and documentation performed in the lab.Serves as reviewer and auditor for SOP revisions and subset audits.
3.May initiate SOP and form revisions, and subset updates.Provides training and guidance to LST I & II(if required).
4.Serves as an owner for GMP equipment & areas and maintains work orders.Demonstrates a thorough working knowledge and understanding of site guidelines,policies,and procedures,including lab and plant regulations, and ensures compliance.
5.Participates, contributes, and may occasionally lead group and project meetings.Works cross-functionally and efficiently in all buildings as well as with internal departments and staff.
6.Responsible for quality of product and services to minimize impact to functional areas. May serve as an area contact for vendor interaction.May initiate project/procedures and utilize resources within the department.
7.Prompt and regular attendance to on-site Amgen workplace.Performs diverse and complex reactions, analyses, and technical procedures, which require the use of advanced techniques, equipment, and instrumentation.
8.Assists in designing and conducting investigational studies.Makes and records observations and performs complex calculations of data to be used for evaluation.
9.Suggests follow-up action to resolve atypical results and problems.Laboratory support functions include setting up and dismantling instruments and apparatus; testing new laboratory equipment, instruments, products, and procedures; and reporting results to supervisor.
10.May be the liaison with vendors on problems with equipment.May act as group lead or assume supervisory responsibilities when required.
11.Shows proficiency on, evaluates, revises and may own area specific SOPs.As required, operates personal computer to maintain spreadsheets and applies various software packages to input or retrieve data and information.
12.Oversees, analyzes, reviews, and presents accurate and timely data entry and reports.Responsible for maintaining and auditing all documentation, SOPs, logbook, subsets, and training records.
13.Initiate and route SOP and form revisions, and subset updates, and serves as an Approver.Provides training and guidance to LST III and below.
14.May lead group and project meetings. Works cross-functionally, efficiently and proactively in all buildings as well as with internal and external departments and staff.
15.Initiates projects and assess and utilizes resources within the department.Responsible for quality of products and services provided to functional areas.
- Extensive knowledge in specialized functions.
- A wide and comprehensive acquaintance with and understanding of both general and specific phases of the job and their practical application to complex problems and situations not ordinarily encountered.
- At lease 2-3 years in a Biotechnology or Pharmaceutical company
- Experience and Basic Knowledge in:
- Aseptic techniques
- LOTO training
- Working with instrumentations (balances, pH, conductivity, Osmometer and BGA)
- Laminal Flow Hood
- Operating Autoclave Equipment to perform a sterilization cycles to Medias and Equipments.
- 3 or more years working with EDM Quality System
- Laboratory documentation review
- Supporting audit process
- Good written and verbal communications skills (English and Spanish)
- Basic computer operation skills in Microsoft Office and other computer software (Word, Excel, Power Point and Interact)
- Performing work orders in Maximo system
- Laboratory activities coordination
- Revising and reconcile booklets and laboratory documentation
- Monitoring expiration dates of the reagents and consumables inventory
Amgen - 13 months ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...