Senior Quality Control (QC) Analyst

Boulder, CO, US

Salary Range:

$93,371.00 - $114,216.00 per year

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

JOB SUMMARY:

Corden Pharma Colorado, Inc. seeks Senior Quality Control (QC) Analyst in Boulder, CO to:

Run routine and advanced analysis on non-routine samples. Works with the Process Chemists and QC Chemists to reach solutions to unresolved problems and train new technicians.
Perform equipment calibration, titrant standardization, and standard validation as required.
Effectively troubleshoot QC Lab instrumentation and methods.
Works with the analytical department on change control for analytical equipment.
Identify and correct problems with instruments in QC Lab. Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist. Research and takes corrective action on anomalous test results.
Perform daily record keeping on SAP and LIMS, print labels, review certificates of analysis, and review final product. Gather and compile data for statistical process control and perform LIMS modification. Peer review analytical data.
Assures that GMP analytical testing complies with Corden SOPs and specifications to ensure favorable quality inspections and customer satisfaction.
Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.
Attend and participate in QC Team meetings. Develop team skills.

No remote work is permitted, position has 12-hour shifts.

JOB REQUIREMENTS:

Requires a Master’s degree in Chemistry, Engineering (any), or related and 2 years of related experience which must include some experience in each of the following skills:

General and organic chemistry principles including identity, assay, purity, potency, pH, solubility, and Karl Fischer titration test methods;
Operating, maintaining, and qualifying analytical lab instruments including HPLC/UPLC, GC, UV-Vis, FTIR, LC-MS, IPC-MS, and pH meters in a CGMP-regulated QC environment;
SAP, OpenLAB CDS, Chromeleon, LIMS, and DataRobot for instrument control, data acquisition, and statistical analysis including time series and regression modeling;
Providing support for routine and non-routine in-process, Final Controls, Stability, and raw material testing and data documentation in a compliant manner using Glovebox operations for handling high potent materials;
Quality Management Systems (QMS), including deviation management, laboratory incident records (LIR), out-of specification (OOS) reporting, change control, and CAPA processes;
Drafting and reviewing technical documents such as SOPs, test methods, validation protocols, and work instructions to ensure regulatory compliance and operational consistency;
Troubleshooting skills and mechanical aptitude to support lab equipment maintenance and ensure continuous lab operation; and
Supporting lab efficiency using lab lean tools (5S) and techniques, and six sigma principals.

This posting will expire on April 24, 2026.

BENEFITS

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service

Accident plan

Critical illness

Dental insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance PPO/HSA

Hospital indemnity plan

ID Theft

Life insurance

Paid maternity/paternity leave

Tuition reimbursement

Wellness Program

Vacation – Three weeks 1st year

Vision insurance

Learn more about this Employer on their Career Site

Sr. QC Analyst