Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials
Job Description
Essential Functions
In-Process Inspections: Regularly observing processes at different stages of production against established quality standards and parameters.
Defect identification, reporting, and resolution: Identifying any non-conforming processes or defects, reporting issues to all relevant individuals and Management, and resolving "quick-fix" issues as necessary.
Data collection and analysis: Document observations and analyze trends in non-forming processes to allow for proactive improvement.
Documentation Review: Inspect in-process documentation and spot check to proactively identify issues that may result in quality events. Stop, notify, and coach all involved individuals.
Communication and collaboration: Working closely with operators, supervisors, and quality engineers to perform trainings and awareness sessions/huddles around commonly-identified gaps.
Education
Bachelor's Degree, preferably in Science or Engineering, or related field preferred
Equivalent combinations of education, training, and relevant work experience may be considered.
Experience
Minimum 4 years' experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD Manufacturing
Experience in cGMP or pharmaceutical, medical device, or related manufacturing industry
Knowledge, Skill, and Requirements
Strong attention to detail and ability to identify defects
Knowledge of quality control methodologies and standards
Understanding of manufacturing processes (preferably pharmaceutical)
Excellent communication and problem-solving skills
Proven ability to work collaboratively with diverse teams
Ability to influence across various different departments and levels
What We Offer:
Competitive salary based on experience.
Annual performance-based bonus and merit increase.
Comprehensive benefits package effective Day 1, including medical, dental, and vision.
Paid Time Off (120 hours per year) plus designated paid holidays.