Supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Performs sampling of water pure steam to support manufacturing activities.
- Performs Environmental Monitoring of aseptic filling rooms and supporting areas.
- Performs bioburden testing of water an in-process samples to detect microorganisms and to obtain information on types and levels of microbial contamination.
- Performs Total Organic Carbon and Conductivity testing on water.
- Maintains laboratory equipment - cleaning and calibration.
- Performs daily, weekly, and monthly lab maintenance and stocks supplies.
- Receives incoming samples for testing.
- Assists with incoming material testing and inventory.
- Performs Swab sampling of manufacturing equipment.
- Complies with applicable GMPs.
- Maintains good practices with regards to processes and /or internal conditions leading to an aseptic environment.
- Maintains laboratory logbooks and other forms to document proper GLP testing.
- Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Open to a flexible and fluid work environment.
- Supports 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.
- Performs all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Ability to interpret and relate Quality standards for implementation and review.
- Proficiency in both written and verbal communication and presentations.
- 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
- 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.
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.