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.

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

Performs all technician tasks accurately and efficiently without supervision. Initiates expert technical advice to customers and completes all tasks in the Technician Training manual. Maintains a high level of housekeeping and attention to detail.

Include the following. Other duties may be assigned.

• Run routine samples of raw materials, intermediates, and final products. Test special request samples from plants, tech center, or process chemists
• Perform equipment calibration, titrant standardization, and standard validation as required
• Identify and correct problems with instruments in QC lab. Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist. Researches and takes corrective action on anomalous test results
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies including GLPs and GMPs
• Perform daily record keeping on SAP and LIMS, enter status changes for raw materials, initiate incident reports, and issue approval-for-use tags
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
• Attend and participate in QC Team meetings. Develop team skills

None.

Every individual is personally responsible for the safety and environmental aspects of his or her 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 (BA) from 4-year college or university; or 1 year of related experience and/or training; or equivalent combination of education and experience. GMP and lab equipment experience preferred.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

None.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required…