Sr. QC Analyst

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people's lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for such purposes as quality control, process control, or product development consistently and accurately. Displays ability to set up and follow procedures independently as directed. Maintains a high level of housekeeping. Displays initiative in completing training, and the ability to train others. Displays high level of attention to detail.

Provides expert technical advice to customers as directed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

* Run routine and advanced analysis on non-routine samples. Work 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

* Identify and correct problems with instruments in the QC Lab. Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist. Research and take corrective action on anomalous test results. Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies, including GLPs and GMPs

* Effectively troubleshoot QC Lab instrumentation and methods

* Perform daily record keeping on SAP and LIMS, print labels, review certificates of analysis, and approve final product. Gather and compile data for statistical process control and perform LIMS modification. Peer review analytical data

* Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste

* Attend and participate in QC Team meetings. Develop team skills

* Take ownership of our own actions and work to achieve the results and goals of the organization

LEADERSHIP & BUDGET RESPONSIBILITIES

Act as Shift Lead in the absence of management

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALITY RESPONSIBILITIES

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy.

CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.…