Job Summary:
Responsible for collecting environmental monitoring samples in the manufacturing processing areas including viable, non-viable, surface, personnel, water and gases as scheduled.
Essential Job Duties:
- Collect environmental monitoring samples in the manufacturing processing areas including viable, non-viable, surface, personnel, water and gases as scheduled.
- Prepare equipment and supplies required for environmental monitoring.
- Will share general responsibilities for monitoring equipment maintenance and calibration, housekeeping, and other support functions (e.g., inventory of consumables and reagents).
- Compile and enter data into computer database (i.e. SAP) to be used for reporting and trending purposes.
- Review test results against specifications.
- Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA regulations.
- Adhere to departmental corporate safety policies.
Job Requirements:
- Associate degree in Microbiology, Biology or closely related scientific discipline is required. Bachelor's degree preferred.
- Equivalency: Depending on the area of assigment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could inlcude 4 years of experience or a Bachelor's degree.
- Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred.
- Requires a basic understanding of the fundamentals of microbiology, aseptic techniques and environmental monitoring.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Must be proactive, results oriented, and have strong attention to detail.
- Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- Excellent verbal and written communication skills in the English language.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Physical Requirements:
Ability to lift or push up to 25 pounds. Ability to stand and/or sit for extended periods - up to four (4) hours at a time. Ability to gown and enter into an aseptic/clean room (65˚F) environment.
4. Manual dexterity to perform clerical type functions such as typing, using a mouse, copying, faxing, etc. Ability to work at a computer and view video display terminal less than 18” away from face for extended periods - up to four (4) hours at a time. Ability to read and review documents for extended periods - up to four (4) hours at a time.
*This job description is accurate at the date of publicationOther duties may be assigned and qualifications required may change over time.. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position.
