Job Title

Requisition

Location

Additional Locations

Job Description

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.

Samples Tested

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:

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.

Documentation Completed to Standards

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

Department Specific Functions

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

QC Tech I - Perform 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 inwet 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.

Education:

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.

Experience:

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

Preferred Skills/Qualifications:

• 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.

Other Skills/Competencies:

• Comply with company policies and procedures.

• Follow safe working practices in the execution of assigned duties.
• Participate in general site and departmental safety initiatives.

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 one's 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.

Compensation: $42,000.00 - $50,000.00