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Manager, QC Microbiology

Boulder, United States

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

Provides direct leadership and management for the Quality Control Microbiology Department in accordance with organizational policies and applicable laws and guidances. Responsibilities include developing employees; planning, assigning, and directing work; meeting goals and performance standards; and driving continuous improvement. Responsible for creating an environment that encourages compliant efficiency, developing and coaching technical staff to improve skills, and ensuring high quality technical work. Create and maintain an industry best in class QC Micro Lab.

Ensures the Quality Control services are provided with optimum compliance and performance. Ensures that process/system boundaries are known and adhered to, and that systems are in place and followed, which support the efficient flow of materials and services into and out of Corden. Represents the highest level of GMP understanding and accomplishment.

Drives continuous improvement in the quality process. Recommends and implements improvements in system and resource deployment. Monitors international and customer compliance expectations and implements systems to ensure expectations are met.

Interfaces with Analytical Research and Corden counterparts. Interacts with the manager of Analytical Research to utilize and manage resources between departments.

Responsible for maintaining Quality Control Systems which support the team’s efforts in the Quality Process (Laboratories, LIMS, SAP, Inventory Control, SharePoint, etc.).

Provides Microbiology expertise while developing or enhancing the programs around environmental monitoring, GMP cleaning requirements for graded rooms, gowning, and water systems. Must have experience contributing or creating contamination control strategies based on the requirements of Annex 1.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

Monitors data quality and accuracy
Maintains laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; and arranging equipment replacement, service, and repair
Maintains laboratory productivity by monitoring workload of Production and Research & Development Departments; identifying peak and slack periods; and making operational or staffing adjustments
Maintains laboratory staff results by counseling and disciplining employees and planning, monitoring, and appraising job results
Routine Quality Control Micro services supplied error free and economically
Drives continuous improvement in the Quality Control Micro Laboratory process
Benchmarks and proposes system improvement and resource deployment
Serves as Quality Control Micro point of contact for internal/external customers and regulatory agencies
Procurement of services and materials provided at optimum cost
Maintains and continually improves QC compliance systems (SOPs, calibrations, training, product approval/release, etc.) to maintain compliance while moving business forward
Utilizes metrics and work plan to track and continually improve performance
Interacts with the manager of Analytical Research to utilize and manage shared resources
Responsible for safe work practices of QC employees
Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
Monitors international regulations and implements systems to ensure compliance with changing regulations
Facilitates and coaches team process. Provides development opportunities for team members
Deep understanding of microbiological techniques, analytical methods, and associated equipment
Provides guidance on subjects related to microbiological principles
Creates programs and procedures related to environmental monitoring, contamination control, gowning, disinfectant efficacy/cleaning, and GMP water monitoring
Attends client meetings and serves as the primary expert on microbiological requirements for new and legacy structures
Manages QC Micro Staff
Assists with deviation investigations and/or own CAPAs
Assists with gowning qualifications, as needed
Trains others, as needed, on microbiological concepts

LEADERSHIP & BUDGET RESPONSIBILITIES

Directly supervises 10 to 15 employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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.

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 4-year college or university; more than 5 years of Pharmaceutical Microbiological Quality Control experience; or equivalent combination of education and experience. QC Microbiology Laboratory experience required including Commissioning of Classified Spaces, Clean Utilities, Routine Monitoring, Release and Stability testing, and Microbiological IDs and interpretation.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

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 frequently exposed to moving mechanical parts, fumes or airborne particles, and low levels of toxic or caustic chemicals. The employee is occasionally exposed to 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.

Demonstrated expertise in organizing, maintaining, and improving lab systems
Excellent written and verbal communication skills
Strong influencing and negotiation skills, and computer skills
Ability to analyze manufacturing requirements and translate requirements to strategies that can be articulated and implemented within the business
Understanding of the basic science and engineering associated with the manufacture of pharmaceuticals
Project management skills, planning, staffing, organizing, directing, and controlling
Analytical problem-solving skills
Leadership and negotiation skills
Ability to build relationships and influence and motivate others
Coaching and mentoring skills
Ability to achieve results through the positive direction of others
Experience in dealing with technical personnel at corporate and customer levels
Strong understanding of microbiological concepts
Ability to independently, or by working in teams, create programs related to microbiological concepts
Ability to lead and/or participate in risk assessments
Strong writing skills
Understanding of FDA guidelines, ISO standards, Annex 1, and other regulatory requirements related to microbiology
Math, reading, and comprehension skills
Good communication and computer skills
Commitment to QHER Principles
Ability to work closely with team members to a common goal
Attention to detail

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 October 24, 2025

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