QA Engineer

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Regular Full-Time Boulder, CO, US 7 days ago Requisition ID: 1811 Salary Range: $90,000.00 To $108,000.00 Annually 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. SUMMARY Leads and assists in Quality Assurance related projects and day-to-day quality activities as needed. Represents the highest level of GMP understanding and accomplishment. ESSENTIALDUTIESAND RESPONSIBILITIES Supports the Quality Assurance Department in the following functions/projects. Responsible for improving the efficiency and effectiveness of all engineering related quality systems. Will have responsibility for generating or reviewing and approving the following document types. Other duties may be assigned. Temperature Mapping Water System Utilities Cleaning Write protocols and reports Annual Product Reviews LEADERSHIP & BUDGETRESPONSIBILITIES Provide 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. 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 Four-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field and 6 years’ experience in Pharmaceutical Development and/or Manufacturing Operations. LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, regulatory and compliance documents. Ability to effectively present information to management and colleagues. MATHEMATICAL SKILLS Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables. 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 and sit. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. 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, 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 wet and/or humid conditions, moving mechanical parts, 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. Knowledge of current Good Manufacturing Practices, ICH Guidelines, and other pertinent national and international regulations Excellent writing, interpretive, presentation, and interpersonal skills Understanding of equipment qualification and validation Good knowledge of good engineering practices and pharmaceutical manufacturing Analytical skills with the ability to function with interdisciplinary teams Proactive approach to problem solving and resolution 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 Critical Illness Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance PPO/HSA Hospital Indemnity Plan ID Theft Life Insurance Tuition Reimbursement Wellness Program 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. #J-18808-Ljbffr