Quality Control Technician 1st Shift

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

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 Description

Job Results & Essential Functions

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 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.

Minimum Requirements

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 sit