Lab Support Specialist
lab support group
GXP, GMP, GLP knowledge is a plus
Bachelors degree with 1-3 yrs exp in pharma or biotech environment
Masters degree will work
High School diploma will not work for this role
5 yrs exp will work if they have been in a junior level role
Should have analytical chemist background working with equipment's
- Responsible for investigation on tolerance equipment
- Will not do calibration nut will manage vendors doing maintenance and calibration of lab equipment's
- Business systems owner for LIMS, ELN
- Checking Temperature monitor system (making sure there are no alarm conditions)
- Make sure to get proper calibration and maintenance scheduled
- Receive stability samples and entered them in to LIMS system
- Working on service requests of lab equipment's with vendors
- Data review and documentation within lab
- Needs GDP experience (Attend annual GMP training)
- Will be working under supervision of a senior person
- Should be present in lab a lot to make sure any equipment coming for scheduled calibration making sure theey meet vendor and escort them in lab and will make sure to take all paperwork and upload them in to client system
- Distribute stability samples to proper lab
- Walk around stability chambers and make sure they are operating properly
- Support analytical and research labs
- Administration of LIMS , ELN
- Calibration and maintenance reports from other vendors
- In charge of stability chambers, humidity profile, trending reports and make sure they are in range and responding to these alarms
Responsibilities:
- Monitor critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules, initiation of service requests and escorting vendors.
- Assist with coordination of set up and qualification activities for new assets.
- Assist with OOT investigations in the Asset Management System.
- Assist with maintenance and monitoring of stability environmental chambers, including routine visual inspection, temperature monitoring trending and coordination of cleaning and maintenance.
- Assist with stability inventory and initialization activities including receiving, storage, distributing and disposal of samples for stability studies.
Required Skills:
- Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
- Experienced in GMP regulated drug development environment.
- Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience.