$31.75 per hr
6 month extendable CONTRACT to HIRE
Shift B-rotation-Confirmed
Week 1
- Wednesday to Saturday: 6:00PM - 5:30AM
Week 2
Thursday to Saturday: 6:00PM - 6:30AM
Shift Differential: 15% additional pay on top of hourly rate for night shift
The shift differential is 15% - note, they train on day shift for 12 weeks, when they move to the night shift, the 15% differential kicks in.
REQUIRED:
- 1+ years of GMP biotech, pharma or medical device industry experience
- Aseptic technique experience OR cell/gene therapy, biologics experience
- Downstream/cell culture ideal is a plus
Essential Functions and Responsibilities:
- Develop a comprehensive understanding of and execute clients GMP proficiently.
- cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
- Supports technical transfer and additional research-level testing activities as needed.
- Perform basic revisions as needed to reflect current procedures accurately.
- Support departmental projects in a contributor capacity.
- May support training sessions as a qualified trainer, ensuring training documentation is maintained.
- Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
- May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required.
- Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
- Must adhere to the clients core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.