Sr. QC Analyst

Job Description

Job Description

CordenPharma 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. 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.

EDUCATION and/or EXPERIENCE

Bachelor's Degree from a 4-year college or university in a related science area and 5 years of GMP experience in a Quality Lab. Master’s Degree from a college or university and 2 years GMP experience in a Quality Lab; or 5 years of related experience in a Quality environment; or equivalent combination of education and experience.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

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 to work with hands; and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• Highly developed analytical skills and knowledge of general or organic chemistry. Specialized skills on non-routine methods
• Ability to demonstrate self-direction in the absence of immediate supervision
• Mechanical aptitude with lab equipment
• Advanced analytical data analysis with ability to detect errors
• Preform general lab duties
• Good communication and presentation skills
• Demonstrated problem-solving skills
• Commitment to QSHE Principles
• Ability to write and revise SOPs and Methods as directed
• Advanced understanding of laboratory software
• Review of analytical data
• Review and execution of method transfers and validations
• Ability to work 12 hour rotating shifts, night or day; weekends and holidays required
• Strong computer skills to include word processing, spreadsheets, e-mail, and database applications

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire June 19, 2026