Job Description
Job Summary:
- Assists and supports the analytical testing of pharmaceutical raw materials, intermediates, finished goods (APIs), stability samples, etc. by compiling and organizing testing kits for Scientists.
- These kits contain the following, but are not limited to: columns, volumetric glassware, labels, prepared mobile phases, sample diluents, filtration media, reference standards, paperwork, etc.
- The technician (kitter) will compile these materials after reviewing the approved analytical method to determine what is needed to perform the analysis.
- Any preparation of mobile phases and or solutions will be accurately recorded in a laboratory notebook or approved testing worksheet/batch record.
- A designated laboratory area will be stocked and maintained to allow for quick and accurate preparation of the kits.
- Kitters will also be responsible for sample log-in paperwork, daily housekeeping of the laboratories including waste disposal, cleaning/drying/storing of glassware, and daily OQ (Operational Qualification) of laboratory equipment such as analytical balances, KF (Karl Fischer) titrators, etc. as needed.
Duties and Responsibilities:
- Follows all Quality Assurance, Standard Operating Procedures, and Environmental Health & Safety requirements.
- Assists with maintaining/ordering of laboratory stock.
- Records/documents all preparation activities.
- Actively engages and assists coworkers to become a valuable team member.
- Independently performs solution preparation calculations (verified by senior chemists).
- Accurately communicates & documents experimental details and results.
- Performs all documentation work according to Good Manufacturing Practices.
- Independently organizes work space for maximum efficiency.
- Performs work in a proactive manner to ensure the analyst has all materials/reagents to perform testing.
- Maintains work areas and laboratory spaces in a clean and compliant manner.
- Must be able to schedule kitting work and priorities to meet business needs.
Education & Experience:
- Typically requires work/study leading to a BS/BA degree in a physical scientific field, i.e., chemistry or biology.
- Experience in a fine chemicals or pharmaceutical testing laboratory is desired.
Equivalency:
- Equivalent combinations of education, training, and relevant work experience may be considered.
Physical Requirements:
- Position requires ordinary ambulatory skills and physical coordination sufficient to move about laboratory locations; ability to stand, walk, stoop, kneel, crouch periodically, manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including the ability to grasp; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
- Will use safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, and organic respirator (occasionally).