Top 3 Quality control analyst ii Jobs in Saint Peters, Mo

Quality Control Analyst II
Sentio BioSciences LLC —Maryland Heights, MO
- $55,000 - $65,000 a year
- Weekends as needed
- English
- Mid-level
- Bachelor's degree
- Health savings account
- Disability insurance
Quick Apply
10d
Audit Analyst II
Cass Information Systems Inc. —St. Louis, MO
- Research
- Mid-level
- 3 years

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Quality Control Analyst II

Sentio BioSciences LLC -
Maryland Heights, MO

Quick Apply

Job Details

Full-time
$55,000 - $65,000 a year
10 days ago

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching
Opportunities for advancement

Qualifications

Teamwork
High-performance liquid chromatographs
Contamination control
English
Data integrity and documentation
Chromatography
Bachelor's degree
Data management
Attention to detail
Pharmaceutical analysis
Laboratory standard operating procedures
Training & development

Full Job Description

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

Quick Apply

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quality control analyst ii jobs in saint peters, mo

Quality Control Analyst II

Audit Analyst II

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