Chemist II, Quality Control Laboratory

Why Endo?

We want the best and brightest people at Endo 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.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Typically supports one Par business, at a single site

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Analysis & Testing

• Conducts laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. 
• Uses laboratory software for analyses

• May review and approve laboratory test data and documentation for completeness and compliance
• Is alert to and detects abnormalities during performances of tests and reviews
• May perform lab methods transfer and participate in method validation/verification studies

65%

Lab Equipment

• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
• Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals

• Learns to troubleshoot instrument/chromatography problems

20%

Investigations

• With guidance, participates in OOS/OOT/NOE and other investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action

• May draft, edit and review SOPs and laboratory investigations

10%

Training

• Maintains assigned training records current and in-compliance

• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

5%

Compliance

• Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting
• Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Follows internal processes related to controlled substances

continuous

Safety

• Follows EH&S procedures to ensure a safe work environment

• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

• Bachelor of Science Degree in chemistry, chemical engineering or related field with 2+ years’ relevant analytical laboratory experience OR
• Master’s Degree in above disciplines with 1+ years’ relevant analytical lab experience preferred

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Demonstrate