JOB SUMMARY
This is a laboratory testing position with the major responsibilities being daily routine testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Technical Expertise:
- Basic understanding of compliance/guidance/regulation pertaining to assigned area.
- Performs routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
- Performs testing competently in at least one to two areas of microbiology or bioassay testing using microbiology techniques, such as, but not limited to:
- Microbiology testing – (purity and filtrate testing)
- Aseptic Technique
- Animal injections preferred (SubQ or ID)
• Laboratory Support (Including Quality Systems):
- Identifies and supports change and continuous improvement using LEAN practices such as 6S+ and Kaizen.
- Conducts initial review.
- Reviews and enters passing results in laboratory information management systems (LIMS).
- Monitor controlled temperature units.
- Receive, label, and restock reagents and supplies.
- Demonstrates proficiency in the use and maintenance of standard laboratory equipment.
- Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
- Maintains the lab and associated areas using the LEAN 5S+ concept.
- Quality Systems:
- Provide input to SOP / Test Method revisions.
- Participates in laboratory investigation, deviation, CAPA, and Change Control activities.
• Problem Solving
- Works on problems of simple to moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Exercises judgement within defined procedures and practices to determine appropriate action.
- Follows good microbiology laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Receives general instructions on routine work, detailed instructions on new assignments.
• Behavior/Cultural Responsibilities:
- Ownership – Actively participate in self-development (IPMP)
- Accountability – Follow through on commitments (PIL, Situational Leadership or additional accountability tools)
- Detail oriented – Able to complete required tasks and associated documentation with minimal error
- Adaptability – Maintain positive attitude in a changing work environment
- Communication – Effectively communicates with all levels of manufacturing and support staff
- Actively participate in department level meetings
- Escalate issues through the proper channels
- Live the Core Values
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor of Science degree in Microbiology or another closely related field preferred.
• 0-2 years' experience preferred, or equivalent level of skill and experience.
• Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
• Animal injection (SubQ or ID) experience preferred
• Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
• An understanding of cGMP, CFR, USP, and aseptic processing guidelines is preferred.
• Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.
• May require work on weekends and holiday’s
