Quality Tech II
Endo
Summary
Perform basic, intermediate or advanced quantitative and qualitative analyses of pharmaceutical components and collection of samples from pharmaceutical equipment.
Job description
Job Results & Essential Functions
- 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.
- 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.
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 II
Perform basic wet chemistry, preparation of reagents/solutions, and sample reconciliation. 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.
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.
Benefits
- Bonus eligible
Company overview
Endo is a diversified specialty pharmaceutical company headquartered in Malvern, Pennsylvania, founded in 1997. As a global pharmaceutical manufacturer, Endo develops and markets high-value branded pharmaceutical products across therapeutic areas including urology, men's health, orthopedics, and endocrinology. The company operates as a subsidiary of Endo International plc and has established itself as a leader in both branded and generic pharmaceuticals, with a portfolio of over 200 product families. Endo's mission focuses on helping everyone they serve live their best life through the delivery of life-enhancing therapies. The company maintains manufacturing and research facilities across multiple continents, including the United States, Ireland, Canada, and India, employing approximately 2,100-3,100 professionals globally. In 2025, Endo completed a significant merger with Mallinckrodt Pharmaceuticals, resulting in the creation of two focused standalone companies: Keenova Therapeutics for branded therapeutics and Par Health for generics and sterile injectables.