Perform routine and non-routine chemical testing of commercial, validation and stability samples in accordance to written methodology
Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC; GC, UV/Vis, KF and FTIR.
Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
Analyze data against approved specifications, notifying management of any OOS and aberrant results
Actively participate in root cause problem solving during laboratory investigations, provide input for effective corrective and preventive actions
Perform routine maintenance on lab equipment as needed
Perform metrology calibrations and preventative maintenance tasks, as needed

Bachelors degree required
A minimum of 3 years of experience in a pharmaceutical environment or similar regulated environment
Basic knowledge and understanding of USP, cGMP and FDA regulations
Create and maintain lab record documentation (notebooks and computer based) according to GMPs
Maintain a clean and safe work environment and follow safety procedures and policies.
Use of Empower and integrated LMS systems
Experience calibrating HPLCS/GC Systems
Ability to maintain, diagnose and work on laboratory instrumentation.

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Quality Control Analyst II

Key skills