This is a 2nd shift role, with working hours of 2 PM to 10:30 PM, Monday through Friday and requires flexibility between 1st and 2nd shift.
The job will encompass the following responsibilities in general:
· Ensure cGMP and Safety standards are maintained in the Manufacturing lines and facilities assigned. Main focus is to continually raise cGMP and Safety standards and reduce or eliminate unplanned deviations.
· Gain a sound understanding of production processes, pharmaceutical cGMP regulations, and ability to implement cGMP in daily QA Ops activities. This includes sound knowledge of ICH Q7 and 21 CFR Part 210/211 and all other applicable regulations.
· Perform Line clearance
· Review and approve critical GMP records generated to support Sentio Biosciences LLC activities. If errors are found, assure that they have been fully investigated and corrected. Such GMP records include, but are not limited to:
- Batch Records (pre- and post-execution)
- Forms and Logbooks
· Deviation, Investigation, Corrective and Preventive Action (CAPA) and Complaint Reports
· Approve or reject all product-related components, containers/closures, labeling and final products.
· Control further processing, or distribution of nonconforming product, until deficiencies or unsatisfactory conditions are corrected.
· Ensure all personnel are appropriately trained.
· Maintain trending for the assigned product lines and escalate to managment any out of trend processes.
· Work closely with manufacturing team to update SOPs, Manufacturing Records, Deviations and any other reports.
· Ensuring facilities and equipment compliance in the Manufacturing suites with active management of housekeeping in the manufacturing lines.
· Participate in regulatory audits.
Background and Experience:
- Bachelors Degree or Associates Degree
- Detailed oriented and open to learning and understanding manufacturing processes
- Sound analytical skills
- Sound communication skills
- Curious and good at investigating
Job Type: Full-time
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- On-the-job training
- Paid time off
- Professional development assistance
- Vision insurance
Application Question(s):
- How many years of Batch Record Review experience do you have?
- How many years of Line Clearance experience do you have?
Education:
Experience:
- cGMP: 3 years (Required)
- Manufacturing Operations Exposure: 2 years (Preferred)
Shift availability:
Ability to Commute:
- Maryland Heights, MO 63043 (Required)
Work Location: In person
