- Function as primary shift technician for environmental monitoring.
- Maintain a state of instrumentation calibration/qualification.
- Performs environmental monitoring of ISO class 5 thru 8 cleanrooms using viable air samplers and non-viable particle counters.
- Collects, analyzes and interprets microbiological testing data.
- Temperature monitoring.
- Reagent preparation.
- Perform routine data entry and data trend analysis.
- Maintain adequate inventory of supplies needed for all microbiological testing including but not limited to pipets, reagents, glassware, and consumables.
- Assists in everyday organization of Microbiology laboratory including cleaning, maintenance and ordering of materials and supplies.
- Perform area cleaning and waste removal, as needed.
- May perform sterilization, gram stains, microscopy and other microbiology related activities
- Prepare solutions and perform other lab duties.
- Helps in evaluating new equipment and internal processes.
- Perform training on laboratory methods and instrumentation, as needed.
- Perform research (read literature, interact with vendors, etc.) on assay methods and instrumentation.
- Must have excellent organizational, written communications and oral communication skills.
- Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of-Specification and failure investigations; recommend possible corrective actions.
- Maintain the safety and orderliness of the lab.
- Other general lab and lab related administrative responsibilities as needed.
- Other duties as needed.
Required Skills & Abilities:
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Follows quality system and Good Laboratories Practices (GLP) compliance.
- Computer proficiency required.
- Apply knowledge of cGMPs on a daily basis, as applicable.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs.
- Ability to accurately complete required documentation.
- Excellent written and oral communication skills.
- Excellent organization, detail oriented and accurate.
- Knowledge of MS Office (Word, Excel, Outlook).
- Ability to work weekends and off-shift hours as needed to support manufacturing activities.
Preferred Skills & Abilities:
- Ability to multi-task and prioritize work assignments with little supervision.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Must be willing to work flexible hours.
- Experience prolonged standing, some bending, stooping, and stretching.
- Ability to sit for long periods to work on a computer.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
- Must be able to lift/push/pull 30 pounds.
- Majority of day spent on feet in the laboratory or clean rooms.
- Attendance is mandatory.
- High school diploma/GED with 2 years of experience.
- Associates degree with 1 year of experience.
- Previous GMP/GLP experience.
- Biotech Certificate.
- Bachelor of Science degree.