Industrial Staffing Services Inc. Quality Technician-Senior in Hobart, New York
Summary of Position
Perform basic, intermediate or advanced quantitative and qualitative analyses of pharmaceutical components, in-process material, finished good product, and/or stability product. Depending on the department to which the incumbent reports some of the functions listed may not be applicable.
Job Results & Essential Functions
A. Performs basic analytical laboratory tests (such as potency, purity, uniformity, dissolution, moisture, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations, including:
a. Performs set-ups, adjustments, calibrations and operation of laboratory equipment and instruments, as well as any associated software.
b. Prepares solutions, solvents, and mobile phases.
c. Accurately prepares, collecst, weighs, and analyzes samples and reference standards, and determines conformance of results to approved specification limits.
B. Independently performs basic investigations for out-of-specification/out-of-trend results.
Documentation Completed to Standards
A. Provides accurate and timely documentation of all procedures, calculations, and results.
Department Specific Functions Completed to Standards
A. Completes LIMS entry, approvals, and data release of products
B. Uses analytical balances, HPLC, GC, KF Titrator, IR, UV, pH Meter, volumetric glassware
C. Performs wet testing like assay titrations, colorimetric tests, TLC, heavy metals, and sieves
D. Flexes skills to other laboratories based on business need
E. Follows established procedures using own discretion and judgment as to the specific approach or technique
F. Identifies/Researches new lab supplies and ordering current lab supplies
G. Identifies and implements cost saving opportunities
H. Sustains laboratory housekeeping and identifies improvement opportunities
I. Completes hands-on and electronic training
J. Participates and leads area huddles or shift meetings
K. Performs other duties as assigned
QC Tech I - Performs basic wet chemistry, preparation of reagents/solutions, and sample reconciliation following approved methods.
QC Tech II - Experienced at some instrumentation and wet testing.
QC Tech III - 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.
Attention to Detail/Focus: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently. Double-checks the accuracy of information and work product to provide accurate and consistent work. Provides information on a timely basis and in a usable form to others who need to act on it. Compares observations of finished work to what is expected to find inconsistencies.
Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.
Follows Processes Consistently: Shows concern for all aspects of the job by accurately checking processes and tasks; carefully and accurately follows established procedures for completing work tasks; uses knowledge that is acquired through formal training or extensive on-the-job experience to perform ones job.
Problem Solving: Rigorously and systematically connects information, processes and events by organizing divergent information and searching for common themes, patterns, and causal connections. Undertakes a complex task by breaking it down into manageable parts in a systematic, detailed way. Thinks of several possible explanations or alternatives for a situation and anticipates potential obstacles and develops contingency plans to overcome them. Uses intelligence, common sense, hard work and tenacity to solve particularly difficult or complicated challenges.
Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
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 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.
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.
Physical Demands/Work Environment
Physical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job:
1. 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.
2. 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.
3. The job involves the ability to judge distance and space relationships, identify and distinguish colors and bring objects within 20 inches into clear focus.
4. Flow of work and character of duties involves focused mental and visual attention much or all of the time.
Environmental/Atmospheric Conditions commonly associated with the performance of the functions of this job:
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.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.