Supports quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to, providing general laboratory support for raw material, in-process, stability, and finished product testing.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Author and execute protocols to support Environmental Qualification of new facility
- Author and execute protocols to support implementation of new laboratory equipment
- Authors Environmental Investigation Reports and Laboratory Investigation Reports
- Create and Revise Test Methods and Standard Operating Procedures to support new facility
- Perform statistical analysis on Environmental data
- Author summary reports for qualification data
- Performs sampling of water and pure steam to support system qualification activities and routine maintenance
- Performs Compressed Air and Gas Sampling and Testing to support system qualification activities and routine maintenance
- Performs Environmental Monitoring of filling rooms and supporting areas to support qualification and routine monitoring
- 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, Endotoxin, Nitrate, and Conductivity testing on water
- Maintains laboratory equipment - including coordination of calibration and preventative maintenance
- Performs daily, weekly, and monthly lab maintenance and stocks supplies
- Receives incoming samples for testing
- Performs incoming material testing and inventory
- Prepares Reagents and Standards used for testing
- Performs Bioburden and Endotoxin testing on client specific raw materials, in-process samples, and finished products.
- Performs testing on biological indicators to support Validation studies
- Performs total spore count on biological indicators
- Performs Growth Promotion on media
- Maintains stock cultures of organisms used for laboratory testing
- Perform microbial identification on isolates
- Reads plates generated from environmental monitoring and laboratory testing
- Data entry of results generated by Laboratory
- Data Trending of results
- 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.
- Reviews Logbooks
- 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 SKILL & ABILITIES
- Proficiency in aseptic technique
- 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
- 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 knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. This level of knowledge is normally acquired through completion of a Bachelor's Degree in Microbiology or a related field and 4-6 years' related work experience. Aseptic experience preferred.
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