What are the responsibilities and job description for the Quality Control Analyst II position at Sentio BioSciences LLC?
Quality Control Analyst will work on the QC lab and will primarily be involved in the analysis and testing of pharmaceutical raw materials, intermediates, APIs and drug products, in a cGMP environment.
The job will encompass the following responsibilities in general:
· Execute all work in compliance with cGMP, good lab practices and safety procedures
· Gain sound knowledge of cGMP regulations, QC SOPs and Standard test procedures for in-house and USP Test Procedures
· Routine sampling and testing of water systems, raw materials, intermediates and finished drug substances and drug products per established test procedures in a cGMP compliant manner.
· Develop and establish proficiency in wet lab, titrators, HPLC, IC, FT-IR, UV and all other lab instruments.
· Perform QC testing on samples, including wet lab, HPLC, IC, FT-IR, UV, Titrators, etc.
· Perform data review of peer QC packets per cGMP guidelines and Sentio procedures.
· Coordinate with third party labs on current and new testing needs.
· Send samples out to third party labs.
· Conduct deviation and out of specification write up and investigation of root cause and CAPA.
· SOP writing.
· Laboratory housekeeping
· Perform QC inventory as per schedule.
· Contamination control in laboratory
· Perform method validation for new test methods and equipment performance qualification.
· Identify, Communicate and implement process improvement ideas and raise quality and safety compliance and standards.
· Ensure compliance with lab data integrity
· Work on R&D and other projects where needed
· Be flexible on work hours & weekend work periodically to support critical schedule requirements
Job Type: Full-time
Pay: $60,000.00 - $65,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- Sentio Requires Drug Screening. Do you expect to pass the screening?
Education:
- Bachelor's (Required)
Experience:
- Quality Control (cGMP Pharmaceutical Analysis): 4 years (Required)
- HPLC: 2 years (Required)
Ability to Commute:
- Maryland Heights, MO 63043 (Required)
Ability to Relocate:
- Maryland Heights, MO 63043: Relocate before starting work (Required)
Work Location: In person
Salary : $60,000 - $65,000
