The Laboratory Technician will provide basic laboratory support to QC laboratory personnel. Assist QC lab analysts with daily lab functions such as organizing, ordering, stocking lab supplies, cleaning, washing glassware, preparing reagents, and measuring using lab equipment. Working under supervision, follow all safety protocols, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and work in accordance with Good Laboratory Practices (GLP) guidelines.
Area Of Responsibility
Work under general supervision and follows established lab procedures and instructions
Follow GMP guidelines and all safety protocols to maintain GMP lab compliance and safety compliance in all labs
Organize and maintain laboratory supplies, reagents, chemicals, and equipment inventories for all QC laboratories. Perform weekly inventory and/or cycle counts (lab audit) as required for all lab supplies and assist in ordering and receiving laboratory supplies and equipment
Daily schedule and operate lab glassware washer and organize lab glassware supplies
Perform weekly lab equipment maintenance, exterior instrument cleaning, general lab organization and cleaning
Maintain records/manual logbooks per good documentation practices (GDPs) including recording daily temperatures and performing daily analytical balance checks.
Receive QC test samples into lab following SOP workflow procedures, monitoring test sample bank inventories, reconcile remaining test samples, to waste stream disposal. Provide email notifications for test sample receipt
Assist with documentation compilation and filing and electronic tracking of tests/documentation
Assist with chemical waste disposal and removal to waste satellite areas
Assist in transport lab gas cylinders to/from warehouse
Deliver shipping requests and samples to warehouse shipping department
Train towards AQL Visual Inspection Qualifications or support visual inspection through physical verification
Support QC Incoming Inspection testing for visual inspection of cosmetic defects and dimensional measurements of product container/closure components by use of calipers. Support QC Incoming Inspection lab when required for measurements and visual inspections
Support Quality Assurance (QA) during Levulan product returns (product complaint) inspections through initial product evaluation and confirmation to the complaint and completing the associated documentation
May possibly prepare lab solution following written SOP/Test Method procedures
Other lab and office duties as assigned
Work Conditions:
GMP Lab environment
Warehouse environment
Office environment
Noise distractions
Exposure to chemical materials
Physical Requirements:
Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch, crawl, talk, and hear.
Visually inspect small items: close, distance, color and peripheral vision; depth perception and ability to keenly focus
Requires, when working in any lab, wearing protective equipment such as lab coat, safety glasses, gloves and breathing protection
Operate basic mechanical tools, i.e. calipers, micrometers, go/no-go gages, and gas cylinder wrenches
Operate computer/office equipment
Able to operate basic laboratory equipment (analytical balances)
Lift up to 30 lbs.
Travel Estimate
0%
Education and Job Qualification
High School diploma, GED or equivalent required; Associate’s Degree preferred
Basic understanding of laboratory environment and laboratory procedures
Basic mechanical skills and able to work with tools (i.e.: calipers, micrometers, go no-go gages, and wrenches)
Good oral and written communication skills and the ability to work with team and management
Experience
Minimum 0-2 years related experience in a Pharmaceutical (FDA Regulated) industry preferred
Good oral and written communication skills and ability to use these skills to follow specific instruction (e.g. written SOPs) and report test/task results to management
Understanding of laboratory safety
Fundamental knowledge of chemical principles
Use of basic laboratory instrumentation, e.g. analytical balance
Basic computer skills (email, Word, Excel)
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).