Description
JOB SUMMARY
Supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing. 12 hour shifts (6am-6p or 6p-6am, Friday through Sunday).
ESSENTIAL DUTIES & RESPONSIBILITIES
Perform sampling of water and pure steam to support manufacturing activities.
Perform Environmental Monitoring of isolator and supporting areas.
Perform bioburden testing of water an in-process samples to detect microorganisms and to obtain information on types and levels of microbial contamination.
Perform Total Organic Carbon, Conductivity, Nitrates, and Endotoxin testing on water.
Perform sampling of compressed gas system to support manufacturing activities.
Maintain laboratory equipment - cleaning and calibration.
Perform daily, weekly, and monthly lab maintenance and stocks supplies.
Receive incoming samples for testing.
Assist with incoming material testing and inventory.
Comply with applicable GMPs.
Maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
Maintain laboratory logbooks and other forms to document proper GLP testing.
Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
Open to a flexible and fluid work environment.
Support GRAM's Core Values of Quality, Service, Collaboration, and Courage.
Support Agency, customer and vendor audits as needed.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned.
Requirements
DESIRED SKILLS & ABILITIES
Ability to interpret and relate Quality standards for implementation and review.
Ability to complete tasks with accuracy and efficiency.
Portrays appropriate levels of integrity and professionalism.
Ability to communicate effectively with management and staff.
Excellent written and verbal skills.
Proficiency in both written and verbal communication and presentations.
Consistently/Frequently - see (vision), hear, ability to read and write, ability to interpret information, basic math, reading and writing in English.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base (internally and externally).
Ability to work well in a cross-functional team environment.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
Qualified candidates have completed a Bachelor's Degree in Microbiology or a related field and 0-2 years' related work experience, or Associate's Degree or HS diploma/GED with a minimum of 3 years' experience. Other laboratory experience may be considered.
GRAM supports Equal Opportunity Employment
