- Perform all job functions safely. Follow safety guidelines, equipment procedures, and chemical handling guidelines. Report any safety deficiencies or safety incidents immediately.
- Develop a thorough understanding of department procedures, quality requirements, performance metrics, and customer requirements. Gain a thorough understanding of the department and how our work impacts our customers. Perform all operations free of operational variances and work with a high degree of precision and accuracy.
- Perform routine lab maintenance and housekeeping per department procedures. Participate in audit readiness initiatives. Report any deficiencies or malfunctions immediately.
- Accurately complete and review documentation per established procedure. Review all data fields, supplies used, labels, and calculations to ensure accuracy and completion per established procedures. Report any ongoing errors to the supervisor.
- Safely operate processing equipment including vapor systems and autoclaves per procedure and report any issues.
- Interact with internal departments to improve safety, maintenance, efficiency, and productivity.
- Report any training deficiencies and identify opportunities to improve procedures and operations.
- Ensure training is accurate and kept updated. Complete training records in a timely manner.
- Adhere to and improve department SOPs, quality compliance GMPs, and other established procedures.
- Adjust to schedule changes, work overtime as necessary, and be willing to support the other Component Prep labs as needed.
- All other duties as assigned.
Required Skills & Abilities:
- Possess effective time management and organizational skills, basic math skills, ability to work independently, and demonstrated strong customer services skills.
- Must have ability to follow written procedures and quality compliance requirements.
- Must possess good problem solving, interpersonal communication, and organizational skills.
- Must have strong initiative and focus on safety, quality, accuracy, and be detail-oriented.
- Ability to lift 40lbs and stand for extended periods of time.
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 able work weekends, off-shifts, and overtime as required
- Attendance is mandatory
- No make-up or jewelry can be worn when working in the clean room environment
- Expected to be on feet standing or walking for up to 90% of shift
- Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and serviced by pressurized steam, water, air and cleaning/sanitizing chemicals systems
- Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers multiple times per shift
- Handle and work with hazardous materials and chemicals per OSHA guidelines
- Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems
- Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions.
- Must be able to work in a team environment.
- High School Diploma or Equivalent
- Experience in a GLP or GMP environment is preferred.
- Biotech certificate