Senior Site Specialist - Quality Control Lab Support

Recruiter
Thermo Fisher
Location
Deal
Salary
Competitive
Posted
12 Sep 2017
Expires
10 Oct 2017
Contract Type
Permanent
Hours
Full Time
Job Description

Knowledge:

Provides general guidance and technical expertise to peers and clients. Utilizes specialized functional area skills and underlying technical principles.

Responsibilities:

  • 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, reagent preparations, 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, 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 media prep documents in standard client procedure format. May use electronic document database to author, route, and review technical documents
  • Perform equipment verifications and calibrations following customer and manufacturers protocols
  • Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
  • Operate specialized laboratory equipment and instrumentation, including Agilent/Waters HPLC systems
  • Initiate Biological Indicator testing
  • At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements
  • Ensures that, equipment, materials, processes and procedures comply with cGMP practices and other applicable regulations
  • Performs review and approval of assay results, documents and records within specified timelines
  • Alerts Customer management of quality, compliance, supply and safety risks
  • Completes required assigned training to permit execution of required tasks
  • Performs additional duties as specified by client contract: consumable inventory management, labware prep (glasswash/autoclave)
  • May operate large and small scale HTST SKIDS, including CIP
  • May track lab equipment information including calibration schedules, open work orders, and equipment status using Computerized Maintenance Management System (CCMS)
  • 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
  • May 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 MSDS

Minimum Requirements/Qualifications:

  • Master's Degree OR
  • Bachelor's Degree & 2 years of Quality experience OR
  • Associate's degree & 6 years of Quality experience OR
  • High school diploma/GED & 8 years of Quality experience
  • Demonstrated verbal, written and presentation skills
  • Displays a high level of confidentiality for both customer and Thermo Fisher Scientific
  • Must maintain Thermo Fisher Scientifics Four-I Values
  • Experience in laboratory setting or services preferred
  • Experience in GLP/GMP environment preferred
  • Proven excellence in customer service skills
  • Detail oriented, problem solver, promotes team environment
  • Computer/software skills (i.e. Outlook, Excel, Word, PowerPoint)

Preferred Qualifications:

  • Demonstrated experience in controlled laboratory processes
  • Demonstrated ability to interpret scientific literature
  • Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
  • Strong communication skills (both written and oral), facilitation
  • Experience executing analytical test method

Non-Negotiable Hiring Criteria:

  • Must be able to work any hours based on the production schedule including but not limited to: non-administrative work hours (second / third shift), weekends, holidays, and variable start times on scheduled working days.
  • 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 deliver excellent customer service to include 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
  • Have demonstrated initiative in previous work experience
  • Expanded tactical thinking that considers the impact on the broader organization
  • Demonstrate the ability to be a team player and place team success ahead of individual goals
  • Must possess a high level of communication skills to provide guidance to others in performing the work, to effectively present information and respond to questions or customer service requests and interact with various levels of the customers organization
  • Must be able to provide suggestions for corrective action and preventive customer service through using process improvement tools
  • Must be organized and detail oriented to be able to prioritize own work and meet business productivity metrics
  • Must be able to apply sound judgment and decision-making skills in dealing with a variety of routine and non-routine issues

Working Conditions:

  • 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 teratogenic, 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

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.