In-Process QC Analyst - DAYS

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.

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

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for such purposes as quality control, process control, 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 a high level of attention to detail.

Include the following. Other duties may be assigned.

• 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's Degree from four-year college or university in Chemistry or related science field and two years' experience in a laboratory; or equivalent combination of education and experience.

Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publications that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical concepts such as significant figures and analysis of variance.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract…