QC LAB TECH II - 1ST SHIFT

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

 

• Receives and collects samples in the LIMS system.
• Performs physical testing on raw materials, in-process materials, finished products, prepackaged items, stability 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 specification or any samples that are atypical from historical trend.
• Performs investigation 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), 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.
• 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 as needed.
• Assists with training and mentoring newer and less experienced lab technicians in lab processes and equipment use.
• Creates, reviews and revises SOP’s for new equipment and processes pertaining to the physicals lab.

• Complies with safety and GMP requirements. 

 

 

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 supervisor immediately. Communicates concerns to supervisor, reports hazards, and provides input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates on 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 the essential functions.

 

EDUCATION and/or EXPERIENCE

• High school diploma or equivalent and minimum of 3 years laboratory experience or a combination of equivalent work experience and higher education (A.S., B.S. or M.S.) will be considered.

• Experience with general laboratory equipment 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 and/or lab processes including but not limited to: Tapped Density, Particle Size Distribution, Karl Fischer Oven and Titrator operation, Liquid Testers (Density, Optical Rotation and Refractive Index), Disintegration, Hardness, Viscosity and SOP updates.

 

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. Reads, understands and follows SOPs. Solid knowledge of testing and inspection processes. Demonstrated ability to consistently meet quality, safety and efficiency goals. Strong problem-solving skills and troubleshooting skills required. Strong time management skills; ability to work well independently; ability to prioritize, calmly handle multiple tasks simultaneously and change tasks frequently in a fast-paced environment.  Demonstrate a strong sense of urgency and flexibility to change tasks frequently.  Strong teamwork skills; ability to work and communicate effectively with others; strong attention to det