Aseptic Manufacturing Technician I/ II (Night Shift)

$31.75 per hr

6 month extendable CONTRACT to HIRE

Shifts: A & B- you must pick A or B shift

Shift A-Rotation-Confirmed

Week 1

• Sunday to Tuesday: 6:00PM – 6:30AM

Week 2

Sunday to Wednesday : 6:00PM – 5:30AM OR

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:

• 2 years of GMP biotech, pharma or medical device industry 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.