Responsible for the proper testing and disposition of raw material, in-process and finished product according to all applicable procedures and guidelines. Performs all aspects of test procedures used, including preparation of solutions and samples, maintenance and calibration of analytical instruments, and interpretation of statistical analyses/results. Prepares and revises test procedures for the laboratory as required. Coordinates laboratory activities and work flow as deemed necessary with other QC laboratory personnel.
Level: Experienced Position Type: Full Time Education Level: 4 Year Degree Travel Percentage: None Job Shift: Rotating 10-hour Shift Job Category: QA – Quality Control
ESSENTIAL RESPONSIBILITIES & FUNCTIONS include the following, others may be assigned.
Performs analysis on bulk and packaged final products utilizing methods that comply with regulatory, compendial (i.e., FCC, USP/NF, EP) or organizational requirements.
Performs analysis on in-process samples to monitor and/or confirm that manufacturing specifications are being met.
Participates in SQC charting of control samples; analyzing variations; and troubleshooting when necessary.
Assures proper quality control of finished product for shipment and releases material in LIMS (Laboratory Information Management System) and SAP (Inventory Management System) as authorized by lab or quality management.
Performs calibration, maintenance, basic diagnostic, and troubleshooting procedures for laboratory instruments as needed.
Assists in managing the Laboratory Information Management System (LIMS).
Generates Certificates of Analysis using the lab computer systems that comply with customer specifications.
In the absence of the QC laboratory supervisor, coordinates laboratory activities and work flow as directed.
Assesses Out-of-Specifications (OOS) results, determines the impact on the product, and ensures timely resolution or corrective action as needed.
Establishes and maintains laboratory supply inventory.
Prepares samples along with necessary paperwork for shipment to potential customers as requested.
Maintains historical records by implementing record keeping systems and filing documents.
Maintains general housekeeping tasks to assure a clean and organized work area. Performs all activities in a safe and conscientious manner.
Understands and follows all organizational policies, procedures and rules, ensuring that all laws are obeyed and equal employment, safety and environmental protection are practiced.
Must be able to work in excess of eight hours per day or forty hours per week on any shift or travel as needed. Normal work schedule includes rotating 1st , 2nd, 3rd shifts and on-call duty as required.
Consistently demonstrates prompt, regular and reliable attendance.
Communicates development and career goals to immediate supervisor and takes ownership of personal development plan.
Contributes to team efforts by accomplishing related results as needed.
Able to handle change productively and other tasks as assigned.
Minimum: Bachelor’s Degree in Chemistry or Biology or minimum of three years equivalent work experience. Preferred: Bachelor’s Degree in Chemistry or Biology
Minimum: Three (3) or more years of experience as a lab technician. Preferred: Five (5) or more years of experience as a lab technician; previous experience as a lab technician in the chemical manufacturing industry (pharmaceutical or food preferred).
Reading/comprehension, speaking and writing at required education equivalency level. Ability to read, analyze and interpret general business correspondence, technical/product information, policies/procedures or government regulations. Ability to complete written forms and write routine to complex procedures, reports and correspondence. Ability to effectively present information and respond to questions in a group or individual setting.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, percent and basic statistical calculations.
Proficient in Microsoft Office applications, including Word, Excel
SAP or similar information management system
The work includes varied duties requiring several different but related processes and methods be applied to a broad range of activities and/or substantial depth of analysis within a particular area. Decisions include areas of established approach, methodology, interpretation or evaluation but also involves generating new ideas or recommendations for process improvements.
The work requires both sedentary and physical exertion to include sitting; walking; standing; bending; carrying/lifting of light and heavy items (up to 50lbs). Work routinely requires speaking and hearing (expression or exchanging ideas by means of spoken words and perceiving sounds by ear).
The work environment requires normal safety precautions typical of such places as laboratories, offices, meeting and training rooms. Requires use of safe work practices with office equipment, avoidance of trips and falls, observance of fire regulations and traffic signals, etc. Generally, the work area is well lighted, heated and ventilated. Environment may include work that requires special safety precautions such as working with irritant chemicals, around moving parts, carts or machines. Employee may be required to use protective clothing or gear such as masks, gowns, coats, safety shoes, boots, goggles, gloves, safety glasses or shields.
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