QC PHYSICAL LAB TECH II - 3RD SHIFT

Essential Duties and Responsibilities

• Collect samples from the Downstairs sample collection area.
• Receive and collect samples in the LIMS system.
• Perform physical testing on raw materials, in-process materials, finished products, prepackaged items, stability samples, REQ samples, and other laboratory samples.
• Perform organoleptic testing, including but not limited to appearance, taste, and odor.
• Record and compare results to specifications; perform secondary reviews.
• Initiate OOS investigations for any samples not meeting specifications or any samples that are atypical from historical trends.
• Perform investigation and/or root cause analyses for any samples in OOS.
• Operate 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 enter laboratory test results into worksheets, Excel spreadsheets, LIMS, and Access database.
• Request samples through Smartsheet as needed to perform the triplicate testing in OOS.
• Perform metal detector checks and temperature checks as needed.
• Read, understand and follow SOPs.
• Promptly answer phone calls, emails, and two-way radio calls.
• Accurately maintain daily logs and equipment logbooks.
• Clean, maintain, and calibrate laboratory equipment.
• Order lab supplies as needed.
• Train and mentor new and less experienced lab technicians.
• Create, review, and revise SOPs for new equipment and processes pertaining to the physical lab.
• Serve as subject matter expert on at least 3 pieces of lab equipment or lab processes which includes troubleshooting knowledge and comfort in operation to train new technicians.
• Comply 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 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.
• Create and review training records for new hires.
• Perform 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

• Support a culture of safe production and exhibit safe work practices.
• Actively participate in the safety program by engaging in safety activities.
• Effectively provide and accept constructive peer-to-peer feedback on safety performance.
• Adhere to policies, procedures, SOPs, safe work practices, and safety policies and procedures.
• Report ALL workplace incidents to the supervisor immediately.
• Communicate concerns to a supervisor, report hazards, and provide input on prevention.
• Properly use, wear, and store Personal Protective Equipment when required.
• Participate in safety teams and/or complete safety-related activities as part of regular job responsibilities.

Qualifications

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

Performance Abilities

• 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 SOPs.
• Solid knowledge of testing and inspection processes.
• Ability to train and mentor newer and/or less experienced lab technicians.
• Demonstrated ability to consistently meet quality, safety, and efficiency goals.
• Good problem-solving skills.
• Good 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 detail skills.
• Ability to create and update SOPs for new equipment and processes in the physicals lab.
• Demonstrated high quality of work.
• Demonstrates and promotes company core values.
• Consistently follows all company policies and procedures, including all safety policies and procedures.
• Ability to work in the physical labs at both the 391 and 395 manufacturing facilities in Bloomingdale.

Language Skills

• Ability to read and interpret documents such as product specifications, departmental instructions, batch records, and procedure manuals.
• Ability to write e-mails to communicate within QC and with operations personnel and to create and update SOPs.
• Ability to collect data for investigations for root cause analysis and troubleshooting processing issues.
• Ability to communicate professionally and effectively both verbally and in writing.
• Ability to accurately complete paperwork, including completing logbooks.

Mathematical Skills

Ability to apply concepts such as fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.

Reasoning Ability

• Ability to compare results to specifications to determine if the result meets requirements.
• Ability to interpret a variety of instructions.
• Good problem-solving skills.

Other Skills and Abilities

• Ability to work on the Production floor as a MQ Inspector as needed.
• Strong computer skills required in Word, Outlook email, and Excel.
• Ability to work a flexible schedule, including weekends to support the business.

Physical Demands

While performing the duties of this job, the employee is frequently required to talk and hear; stand and/or walk throughout the facility; ascend and/or descend stairs; use hands to finger, handle, and feel; and reach with hands and arms. The employee is regularly required to enter information into a computer, handle products in various stages and forms (raw materials, in-process, and finished products in liquid, powdered, capsule, softgel, and tablet forms), and handle testing equipment, raw materials, and finished product, tools and/or controls. The employee frequently is required to use their sense of taste, sight, and smell. The employee is occasionally required to reach, balance, or stoop. Specific vision abilities required include close vision and color vision.

The employee must regularly lift, move (in some cases drag items), slide, raise, and/or place:

• Lift 15 lbs. from ground level and place at 61-inch level; return to the original position.
• Push up to 30 lb. force for up to 25 feet and then pull to the original position.
• Carry 20 lbs. for 3 feet at waist level; lift bag/box onto the side and return to the original position.

Work Environment

While performing the duties of this job, the employee regularly works near moving mechanical parts. The employee is frequently exposed to herbal aromas, dust, and/or airborne particles, some classified as allergens or irritants. This position works in all areas of the manufacturing facilities with direct exposure to ingredients (powders and liquids), mixes (powders and liquids), equipment, and packaging. The employee may occasionally be exposed to potentially hazardous chemicals. The noise level in the work environment is usually moderately loud, and in some areas hearing protection is required.