Process QC Analyst - NIGHTS

Corden Pharma

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.

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

This is a night shift opportunity which has a 18% shift differential in addition to the base pay.

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

• Run standard and advanced analysis in-process, raw material, intermediate and final release samples in compliance with applicable quality systems to meet development and/or customer service needs.
• May analyze batches of drug substance and/or intermediates to be used in clinical or registration programs. Handles potent materials per applicable procedures and training as needed.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• Responsible for training new chemists as needed.
• Ensures that laboratory productivity and turnaround goals are met through timely completion and peer‑review of laboratory testing.
• Ensures laboratory equipment and materials are maintained; and systems are understood and followed in a manner that facilitates efficient laboratory operation. Performs equipment calibration, titrant standardization, and standard validation as required.
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies, including GLPs, GMPs, and 5S practices.
• Performs daily record keeping on LIMS and related systems and print labels.
• Identifies, troubleshoots, and/or corrects problems with methods and instruments in QC Labs. Successfully communicates these activities to appropriate individuals, teams, supervisors and/or managers.
• Researches and takes corrective action on anomalous test results as required. Collaborates with method owners as necessary.
• May attend and participate in Technical Team meetings as appropriate. Develops team skills through training and mentorship.
• May facilitate and support analytical technology transfers, including validation of analytical methods and procedures.
• May participate in manufacturing site activities, such as troubleshooting and analytical problem resolving.
• Responsible for properly managing the generation and accumulation of hazardous and non‑hazardous waste.

Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons.

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.…