Sr. QC Analyst

Corden Pharma Colorado•Boulder, CO

13h•Onsite

About The Position

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.

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
Supporting lab efficiency using lab lean tools (5S) and techniques, and six sigma principals.

Responsibilities

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.

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