Quality Control Tech

Endo•Hobart, NY

6d•Onsite

About The Position

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day. Perform basic, intermediate or advanced quantitative and qualitative analyses of pharmaceutical components and collection of samples from pharmaceutical equipment.

Requirements

Bachelor Degree in science related field (Chemistry, Biology) is preferred or Associates Degree with equivalent combination of education, experience competencies accepted.
Tech II: Working knowledge of chemistry required
Tech III: Minimum 1-3 years of experience in a cGMP facility
Perform basic functions of arithmetic: add, subtract, multiply and divide all units of measure.
Perform reading, writing and speaking at a basic level.
Basic computer skills including Word, Excel and database software.
Basic to advanced knowledge of chemistry
Ability to understand and apply cGMP, SOP, and DEA regulations.
Ability to deal with and solve problems of moderate difficulty.
Self-motivated, demonstrates initiative, able to make good decisions under pressure.
Possess sufficient interpersonal skills to be able to function as part of a team.
Attention to detail and accuracy.
Ability to learn and apply technical concepts rapidly.
Comply with company policies and procedures.
Follow safe working practices in the execution of assigned duties.
Participate in general site and departmental safety initiatives.
The job involves sitting, walking, and standing, reaching, talking and hearing.
Job requires to exert a negligible amount of force continuously and up to 50 pounds of force occasionally to lift, carry, push, pull or move objects.
Depending on task will be on standing or moving majority of the day. Some tasks will require sitting a desk/bench performing work on a computer.
The job involves the ability to judge distance and space relationships, identify and distinguish colors and bring objects within 20 inches into clear focus.
Flow of work and character of duties involves focused mental and visual attention much or all of the time.
Will require interaction and sample collection in other manufacturing and packaging departments.
Typical laboratory work environment.
Exposure to pure chemicals, raw materials, and product requires safety precautions and use of lab coat, safety glasses, gloves, dust mask/respirator, safety shoes and/or booties as outlined in MSDS.
Work hazards include proximity to chemicals and solutions, exposure to dust, odors, cleaning solvents, noise, vibration, and poor ventilation.
Some elements present that make conditions less desirable than usually found in an office environment.
During sample collection additional gowning requirements are required including the use of disposable coveralls, gloves, booties and sleeve guards.

Nice To Haves

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.

Responsibilities

Perform basic analytical laboratory tests (such as potency, microbial sample collection, concentration of materials, moisture, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations, including: a. Set-up, adjustment, calibration and operation of laboratory equipment and instruments, as well as any associated software. b. Prepare solutions, solvents, and mobile phases. c. 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.
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.