QC Specialist, Microbiology

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

Is responsible for administering the GMP Environmental Monitoring Program for the site for classified spaces for production, packaging, sampling, dispensing, and testing.  This person will serve as a Subject Matter Expert for one or multiple microbiological programs. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

Responsible for ensuring the operational nature and conformance of manufacturing spaces to meet stated requirements for protection of the product in regard to GMP. This includes the following:

Additionally, as required, perform Microbiology sampling and testing according to SOP including, but not limited to the following: 

• Isolates and makes cultures of significant bacteria or other micro-organisms in prescribed or standard inhibitory media, controlling factors such as moisture, aeration, temperature, and nutrition
• Identifies micro-organisms by microscopic examination of physiological, morphological, and cultural characteristics
• Performs endotoxin analysis using turbidimetric and gel clot methods on water and product samples
• Maintains Micro Lab including supply ordering, sterilization, instrument maintenance, and calibration
• Generates methods and standard operating procedures relevant to the Micro Lab
• Participates in required investigations, including review of microbial deviation issues or risk assessments
• Participates in Regulatory Audits
• Attends and participates in QC Team meetings. Develops team’s skills
• Site water activities including coordination of samples with external labs
  1. Weekly water samples 
  2. Critical water samples for investigation to be performed on site
• Investigation of samples
• API samples for lot release for all products
  1. Includes performing testing for TAMC/TYMC within 24 hours of receipt
• Microbiological Program and Microbiological lab improvements for continuous improvement
• Establishment and maintenance of 5S/Lean Lab Principles
• Trains QC Staff on new Microbiological procedures and processes
• Qualify new media
• Viable and non-viable air sampling
• Maintaining data sources and trending for the environments/utilities

LEADERSHIP & BUDGET RESPONSIBILITIES

None.

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 (BA) from a four-year college or university in Microbiology; and five years related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as proportions, percentages, area, and volume. Ability to apply concepts of basic algebra.

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 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral 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.

• Strong math, reading, and comprehension skills
• Mechanical aptitude with lab equipment
• Support QC staff with general lab duties
• Preform microbial methods on test samples
• Good communication skills and computer skills
• Commitment to Quality and SHE Principles
• Ability to work closely with team members to a common goal
• Attention to detail
• Ability to work on 12 hour rotating shifts, night or day; weekends and holidays required

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 February 27, 2026