Sr Site Specialist
|Title:||Sr Site Specialist|
|Location:||Thousand Oaks, CA|
Immediate need for a Sr Site Specialist
Duration: 1 year +
Location: Thousand Oaks, CA
- Perform complex calculations based on Molarity, percent by volume, dilutions, ppm, and ppb.
- Prepare high quality specialized media, including buffers, microbial agar plates, mammalian cell culture media, and antibiotics
- Perform specific tasks associated with media prep, including but not limited to pH titration, osmolality adjustment, sterile filtration techniques, and aliquots
- Verification, calibration, and use of common and specialized lab equipment including, but not limited to magnetic mixer, hot plate, micropipettors, autoclave, balances, laminar flow and fume hoods, pH and conductivity meters, osmometers, Blood Gas Analyzers, vacuum filtration, peristaltic pumps, and Nitrogen gas lines
- Verification of peer calculations, technical documentation, equipment log books, and approval of completed documents
- Technical writing of all media prep documents in standard Media Request procedure format. May use electronic document database to author, route, and review technical documents
- Archival of all completed documentation and log book forms with customer archiving group
- Perform equipment verifications and calibrations following customer and manufacturers protocols
- Promote a safe work environment through various safety initiatives within functional area
- Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings
- Can engage in training activities with new-hires when working in conjunction with a Site Supervisor
- May prepare media for shipment for off-site use, including classifying media hazard category and providing required SDS
Additional GLP Responsibilities:
- Prepare high quality GLP media for pre-clinical client base
- Perform GLP equipment verifications and calibrations following customer SOP's
- Verify GLP equipment log book entries, including calculations
- Review completed GLP log forms including but not limited to balance verification, pH meter, Chain of Custody, and Chemical Inventory review
- Perform quarterly GLP chemical inventory review following customer SOP guidelines
- May participate in quarterly GLP binder review sessions
- Fully trained on equipment monitoring for CEMS.
- May have responsibility for responding and inhibiting CEMS alarms, monitoring and trending Controlled Environmental Monitoring System data for GLP refrigeration units
- May use CCMS to track equipment data and standards calibration reports
- Maintain Good Documentation Practices by following customer SOPs
- May serve as Subject Matter Expert (SME) for GLP regulatory procedures for new or existing GLP client groups
- Verify and determine the regulatory status or all requested GLP media requests
- Maintain annual GLP training through customer's Learning Management System
- Maintain a current resume with up to date job title, description, and dates, in the Unity Lab Services binder. To be made available in the event of a regulatory audit request
- May work with GLP client groups to train and provide SME to outsourced media when needed
- Provide copies of all requested completed documents to GLP clients or GCA when requested
- Participate in PPI projects to eliminate waste and increase productivity
- Works primarily at customer locations, in office environment to include cubicles and/or in and around shipping/receiving docks, stock rooms, storage locations and laboratory environments
- May be required to work independently within customer location
- Extensive walking/standing may be required for 75-85% of the day
- May pass through areas where chemical based allergens may be in use (such as penicillin, tetracycline, etc.)
- Must be able to work with carcinogenic, mutagenic, and irritant classified chemicals including Sodium Azide and Thimerosal
- Must possess motor skills appropriate to the task
- Must be able to lift, push and pull 30-40 pounds consistently; may be required to lift 50 lbs.
- May be able to use material handling equipment such as push carts and pallet jacks
- Depending on area of building, personal protective equipment may be worn to include lab coats, coveralls, hood, facemask, hairnets and/or safety gloves
- Some areas require steel toe shoes, bump hats and/or safety glasses
- Must be able to work hours required to get the job done
- Must possess a minimum Bachelors Degree preferred or 2+ year's equivalent experience in a lab setting. Education in Life Sciences and familiarity with scientific lab environment including basic concepts such as units of measure for solids and liquids.
- Demonstrated verbal, written and presentation skills
- 1-3 years of progressive relevant experience required
- Displays a high level of confidentiality for both customer and client
- Must maintain clients Four-I Values
- Experience in laboratory setting or services preferred
- Experience in GLP/GMP environment a plus
- Proven excellence in customer service skills
- Detail oriented, problem solver, promotes team environment
- Computer/software skills (i.e. Outlook, Excel, Word, PowerPoint)
- Must possess a strong desire to serve the customer, and the interpersonal skills to deal with various levels of personnel at the customer site.
- Must possess strong communication skills and customer focus to deliver excellent customer service including maintaining a professional appearance at all times.
- Must possess the operating skills to use hand held scanners and learn to enter data in various systems as necessary.
- Must possess strong analytical skills to reconcile various reports to ensure customer requirements are met.
- Must possess the organizational skills to multi-task and meet deadlines as needed.
- Must be able to use a computer and possess intermediate skills in Microsoft Office suite.