Sr. QA Systems Specialist

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 support that facilitates seamless execution of the overall objectives of the Quality Department. Supports the administration of Quality Assurance documentation programs, procedures, and controls, ensuring that performance and quality of products conform to established Corden Pharma (CP) standards and federal regulations. The Sr. QA Systems Specialist plays a key role in ensuring the organization maintains a robust, inspection-ready Quality Management System (QMS) in alignment with global pharmaceutical and life sciences regulatory expectations. This role oversees regulatory surveillance, corporate standard governance, pharmacopeial compliance, risk assessments, and data integrity initiatives. The specialist partners cross-functionally to maintain compliance and drive continuous improvement. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. Manages the site level Corporate Compliance Standard implementation process. Maintains compliance with corporate standards by collaborating with SMEs to perform gap assessments and track implementation of updates Coordinates site level programs for tracking regulatory and compendial updates. Communicates updates to relevant stakeholders and supports implementation activities Maintains customer Quality Assurance Agreements (QAA). Works closely with the customers, project managers, and internal stakeholders to ensure QAAs accurately reflect roles, responsibilities and GMP compliance expectations Acts as the site's subject matter expert for quality risk management procedures and associated software. Develops QRM training and facilitates the performance of cross-functional risk assessments (e.g. FMEA, HACCP, ICH Q9 principles) Supports adherence to ALCOA++ and data integrity principles across the QMS. Participates in data integrity assessments, investigations, and remediation initiatives. Develops and delivers training and awareness programs related to data integrity principles. Owns and manages quality records to closure due dates including, but not limited, to deviations, change control, and corrective actions, and Preventative Actions (CAPAs) Supports regulatory inspections, customer audits and internal audits Compiles and communicates departmental metrics, as needed. LEADERSHIP & BUDGET RESPONSIBILITIES Provides guidance and leadership where appropriate. 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 Harmonization 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 in Science and 8 years of Quality Assurance experience within the Pharmaceutical Industry; or an equivalent combination of education and Pharmaceutical Industry experience. LANGUAGE SKILLS Ability to read and comprehend instructions, communications, and the intent of regulatory documentation. Ability to write instructions, communications, and general procedures. Ability to effectively communicate information in one-on-one and small group situations to Quality Department customers and vendors, regulatory authorities, and other employees of the organization. Ability to respond to common inquiries or complaints from customers, regulatory agencies, top management, and peers. MATHEMATICAL SKILLS 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 comprehend and carry out instructions furnished in written, oral, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to identify and address interpersonal issues in a professional business manner. 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 talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; 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 visual 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 fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. 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 necessities. Ability to work with minimal supervision on complex projects Extremely organized and detail oriented. Ability to balance multiple priorities in a dynamic, fast-paced environment Demonstrated ability to collaborate and communicate across all levels of the organization, as well as with customers Experience supporting regulatory inspections (FDA, EMA etc.) and customer audits Working knowledge of Quality Management Systems and regulatory requirements (e.g. FDA, EMA, ICH, PDMA, USP) Experience with electronic QMS platforms (e.g. MasterControl, TrackWise) Strong risk management and data integrity knowledge Strong analytical and problem-solving skills Excellent communication and interpersonal skills; able to influence cross-functionally Project management training or certification (PMP, Lean Six Sigma), preferred Experience working in a GMP API/DS manufacturing environment, preferred 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 March 16, 2026

Created: 2026-03-04