QC Physical Lab Technician I - 2nd Shift

Tests and inspects raw materials, in-process materials, finished products, stability, and other laboratory samples and conducts physical and organoleptic testing at the 391 and 395 facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Collects samples from the sample collection area.
• Receives and collects samples in the LIMS system.
• Performs physical testing on raw materials, in-process materials, finished products, prepackaged items, stability samples, REQ samples, and other laboratory samples.
• Performs organoleptic testing, including, but not limited to appearance, taste, and odor
• Records and compares results to specifications and performs secondary reviews.
• Initiates OOS investigations for any samples not meeting specifications or any samples that are atypical from historical trends. Performs retest and/or root cause analysis for any samples in OOS.
• · Operates equipment in all of the following pieces of lab equipment, including but not limited to: pH meter, FTIR, NIR, disintegration apparatus, moisture analyzer, automatic tablet tester (hardness, weight, length, thickness), Anton Paar modular unit (density meter, refractometer, polarimeter), Rudolph modular unit (density meter, refractometer, polarimeter), automatic titrator (acid value, Karl Fischer), Karl Fischer oven, powder density tester, sonic sifter, friability apparatus, density by pycnometer, water activity meter, melting point apparatus, viscometer, balance, loss on drying oven.
• Accurately enters laboratory test results into worksheets, Excel spreadsheets, LIMS, and Access database.
• Uploads testing documents to Epicor; enters Product code/Lot number/Stability number and REQ number accurately in the Epicor system; and performs final Review paperwork in the Epicor system.
• Requests samples through Smartsheet to perform the triplicate testing in OOS.
• Performs metal detector checks and temperature checks as needed.
• Promptly answers phone calls, emails, and two-way radio calls and follows up.
• Accurately maintains daily logs and equipment logbooks.
• Cleans, maintains, and calibrates laboratory equipment.
• Orders lab supplies and restocks PPE in the lab as needed.
• Safely moves hazardous waste from the Physical Lab to the Analytical safety waste room.
• Identifies and submits suggestions to improve safety, quality and efficiencies.
• Complies with safety and GMP requirements.

SAFETY RESPONSIBILITY STATEMENT

Supports a culture of safe production and laboratory practices and exhibits safe work practices. Actively participates in the safety program by engaging in safety activities. Effectively provides and accepts constructive peer-to-peer feedback on safety performance. Adheres to policies, procedures, SOP’s, safe work practices, and safety policies and procedures. Reports ALL workplace incidents to the supervisor immediately. Communicate concerns to a supervisor, report hazards, and provide input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates in safety teams and/or completes safety-related activities as part of regular job responsibilities.