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Endo · 1 month ago

Quality Control Technician 1st Shift

Hobart, NY

Full-time

Onsite

Entry, Mid Level

1+ years exp

Endo is dedicated to developing and delivering life-enhancing products through focused execution. The Quality Control Technician will perform quantitative and qualitative analyses of pharmaceutical components and ensure compliance with cGMP, FDA, and DEA regulations.

Pharmaceuticals

Comp. & Benefits

Responsibilities

Perform basic analytical laboratory tests (such as potency, purity, uniformity, dissolution, moisture, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations, including:

Set-up, adjustment, calibration and operation of laboratory equipment and instruments, as well as any associated software

Prepare solutions, solvents, and mobile phases

Accurately prepare, collect, weigh, and analyze samples and reference standards, and determine conformance of results to approved specification limits

Assist in basic investigations for out-of-specification/out-of-trend results

Provides accurate and timely documentation of all procedures, calculations, and results

LIMS entry, approval, and data release of products

Use analytical balances, HPLC, GC, KF Titrator, IR, UV, pH Meter, volumetric glassware

Perform wet testing like assay titrations, colorimetric tests, TLC, heavy metals, and sieves

Flex skills to other laboratories based on business need

Follow established procedures using own discretion and judgment as to the specific approach or technique

Identify/Research new lab supplies and ordering current lab supplies

Identify and implement cost saving opportunities

Sustain laboratory housekeeping and identify improvement opportunities

Complete hands-on and electronic training

Participate and lead area huddles or shift meetings

Perform other duties as assigned

Perform basic wet chemistry, preparation of reagents/solutions, and sample reconciliation following approved methods

Experienced at some instrumentation and wet testing

Expert in wet chemistry analysis and instrumentation analysis performed by laboratory

Ability to perform some instrument maintenance and troubleshooting chromatography issues

Trainer for areas of proficiency

Perform peer review and release of all products, participate in validations, and execute Gage R&R experiments

Initiates and supports Out of Specification, Out of Trend, and Exception Investigations

Identify method improvements and perform change controls

Regularly uses communication skills to exchange information, especially technical information within the lab and with other departments

Qualification

CGMP regulationsHPLCWet chemistryAnalytical balancesData analysisProblem solvingTechnical learningBasic computer skillsTeam collaborationAttention to detail

Required

High School Diploma or equivalent required

Bachelor Degree in science related field (Chemistry, Biology) is preferred or Associates Degree with equivalent combination of education, experience, and competencies accepted

Tech I: Classroom or previous work experience in a science related field

Tech II: Working knowledge of chemistry required

Tech III: Minimum 1-3 years of experience in a cGMP facility

Perform basic analytical laboratory tests (such as potency, purity, uniformity, dissolution, moisture, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations