Overview

Quality Control Analyst II Jobs in Maryland Heights, MO at Sentio BioSciences LLC

The Quality Control Analyst II performs intermediate level laboratory testing and analysis to support raw material, in-process, stability, and finished product testing in compliance with Good Manufacturing Practices (GMP). This role involves routine analysis, executing validated methods/transfers, learning to troubleshoot issues and contributing to continuous improvement initiatives within the QC laboratory.

Key Responsibilities

Laboratory Testing and Analytical Support:

  • Execute HPLC/IC analysis using Chromeleon CDS for routine and method development/transfer.
  • Perform wet lab, titrators, FT-IR, UV and all other analytical instruments.
  • Ability to quickly internalize and operate within Sentio’s domain-specific workflows, SOPs, and analytical standards with minimal oversight after Sentio qualification.
  • Perform routine and non-routine chemical, physical, and microbiological sampling and testing on raw materials, intermediates, and finished products in cGMP compliant manner.
  • Execute stability studies in accordance with established protocols.
  • Accurately record, analyze, and interpret test results to ensure product quality and compliance with specifications.
  • Coordinate with third party laboratories for outsourced testing and manage sample submissions.
  • Active participation in laboratory housekeeping and contamination control
  • Perform QC inventory as per schedule.

Documentation & Compliance:

  • Maintain detailed and accurate laboratory records in accordance with GMP, ALCOA++ principles and company SOPs.
  • Review and verify data for accuracy and compliance prior to submission.
  • Perform data review of peer QC packets per cGMP guidelines and Sentio procedures.
  • Proven ability to develop, revise and maintain test methods, SOPs, and associated cGMP documentation in accordance with quality systems requirements.

Equipment & Troubleshooting:

  • Operate, calibrate, and maintain laboratory instruments (e.g., HPLC, IC, UV-Vis, FTIR, dissolution testers, balances, pH meters, polarimeter, colorimeter).
  • Identify, troubleshoot, and escalate instrument or testing issues as needed.

Quality & Continuous Improvement:

  • Collaborates with QC, QA and Cross functional teams to support investigations of out-of-specification (OOS), out-of-trend (OOT), and deviation investigations and ensure timely closure.
  • Propose and implement improvements to laboratory practices, workflows, and data integrity controls.
  • Ensure compliance with internal policies and applicable regulatory requirements (FDA, ICH, USP).

Collaboration & Mentorship:

  • Provide training and guidance to QC analysts (level I).
  • Work closely with Quality Assurance, Manufacturing, and R&D, to support production and release timelines.
  • Communicate effectively with team members and management regarding test progress, issues, and results.

Qualifications

Education:

  • Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

Experience:

  • 5+ years of relevant QC laboratory experience in a GMP-regulated environment including 2+ years of HPLC experience.
  • Experience with analytical instruments such as HPLC, FTIR, UV-Vis preferred. Bioburden testing a plus.

Skills & Competencies:

  • Strong knowledge of GMP and regulatory testing requirements.
  • Ability to analyze data, identify trends, and resolve technical problems.
  • Proficiency in laboratory information management systems (LIMS), Empower, or similar software.
  • Strong written and verbal communication skills.
  • Ability to prioritize workload and meet deadlines in a fast-paced environment.
  • High attention to detail and commitment to data integrity.

Working Conditions

  • Laboratory environment with exposure to chemicals, reagents, and biological materials (appropriate PPE required).
  • Extended periods of standing and handling laboratory equipment.
  • May require occasional evening or weekend work to support production schedules.

Career Path & Growth

  • Opportunity to advance to QC Analyst III, Senior QC Analyst, QC Supervisor roles depending on performance, expertise, and leadership contributions.

Benefits

  • 10 Days PTO plus select national holidays / 15 days after 2 years / 20 days PTO after 5 years
  • Health insurance (employer and employee contribution) (Eligible on start)
  • Vision (employer contribution)
  • Dental (employee contribution)
  • 401 (k) with 3% employer contribution (eligible after 3 months)
  • Short Term and Long Term Disability (employer contribution)

Job Type: Full-time

Pay: $55,000.00 – $65,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Health savings account
  • Paid time off
  • Vision insurance

People with a criminal record are encouraged to apply

Education:

  • Bachelor’s (Required)

Experience:

  • Analytical chemistry testing: 5 years (Required)
  • HPLC: 2 years (Required)

Language:

  • English (Required)

Ability to Commute:

  • Maryland Heights, MO 63043 (Required)

Work Location: In person

Title: Quality Control Analyst II

Company: Sentio BioSciences LLC

Location: Maryland Heights, MO

Category:

 

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