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.