QC PHYSICAL LAB TECH II - 3RD SHIFT

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

 

• Collect samples from the Downstairs 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. Also, performs secondary reviews.
• Initiates OOS investigations for any samples not meeting specifications or any samples that are atypical from historical trends.
• Performs investigation and/or root cause analyses 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.
• Requests samples through Smartsheet as needed to perform the triplicate testing in OOS.

• Performs metal detector checks and temperature checks as needed.
• Reads, understands and follows SOPs.
• Promptly answers phone calls, emails, and two-way radio calls.
• Accurately maintains daily logs and equipment logbooks.
• Cleans, maintains, and calibrates laboratory equipment.

• Orders lab supplies as needed.
• Trains and mentors new and less experienced lab technicians.
• Creates, reviews, and revises SOP’s for new equipment and processes pertaining to the physical lab.
• Subject matter expert on at least 3 pieces of lab equipment or lab processes which includes troubleshooting knowledge and comfort in operation to train the new techs.

• Complies with safety and GMP requirements. 
• Restock PPE in the lab when needed.
• Safely move Hazardous waste from the physical lab to the Analytical safety waste room.
• Upload the documents to Epicor accurately.
• Enter Product code/Lot number/Stability number and REQ number accurately in the Epicor system.
• Final Review paperwork in the Epicor system.
• Creates and reviews training records for new hires.
• Performs retest and/or root cause analysis for any samples in OOS.
• Prioritize liquid mix samples in the lab for testing.
• Prioritize powder mix samples in the lab for testing.

 

 

SAFETY RESPONSIBILITY STATEMENT

Supports a culture of safe production 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. 

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions.

 

EDUCATION and/or EXPERIENCE

• High school diploma or equivalent and minimum of 3 years laboratory experience
• Experience with general laboratory equipment is required.  

 

PERFORMANCE ABILITY

Demonstrated ability to perform all of the duties of the Quality Control Lab Technician I and II positions.  Subject matter expert on at least 3 pieces of lab equipment or lab processes.

 

Proven ability to accurately conduct physical and organoleptic testing and inspect raw materials, in-process materials, finished products, and other laboratory samples according to set standards and SOP’s. Solid knowledge of tes