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The position encompasses biological, chemical, and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods and environmental monitoring programs. This is a first shift position working onsite.
Job Responsibility:
Conduct critical chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs
work under minimum supervision
serve as mentor to Quality Laboratory Associate I positions
provide training and work direction for Quality Laboratory Associate I positions
perform review of test data including overall documentation practices
perform release functions in LIMS or other computerized systems
use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems
perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
complete all testing including special project/protocol testing in a timely and appropriate manner
maintain data integrity
ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
participate in team functions impacting production, increasing efficiency, solving problems
perform laboratory and manufacturing audits
audit and update plant SOPs
maintain quality records and lab cleanliness
assume responsibility for lab area's upkeep
investigate deviations and write exception documents
support improvement projects using LEAN management principles
communicate with peers and management to ensure awareness of progress and issues
recommend solutions
maintain the highest standards in quality, customer service, and regulatory compliance.
Requirements:
Bachelor degree in Chemistry or physical science with 2 or more years' experience
good oral and written communication skills
strong analytical skills
being detail-oriented
knowledge of current Good Manufacturing Practices preferred
advanced laboratory skills with basic knowledge of statistical methods
strong technical problem solving skills
ability to handle multiple tasks concurrently and in a timely fashion
knowledge of Empower Chromatography Data System and LIMS preferred but not required
knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines preferred but not required
effectiveness in training others
empowerment
leadership
results orientation
task completion
ability to work independently and as part of a team
self-motivation
adaptability
positive attitude in a highly dynamic environment
ability to lift up to 50 pounds
not being color blind.
Nice to have:
Knowledge of Empower Chromatography Data System
Knowledge of GLP, cGMP requirements
familiarity with USP/ICH guidelines
What we offer:
Support for parents
continuing education/professional development
employee health and well-being benefits
paid time off
2 days a year to volunteer
medical and dental coverage
insurance coverage for basic life, accident, short-term and long-term disability
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