Sr. QA Associate

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. CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. SUMMARY Administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations. Works directly with manufacturing and support groups to address quality issues with cGMP activities. Participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs Acting as the QA Representative on project teams as needed Is the QA Generalist and resource on cGMP issues, who understands cGMP, Data Integrity, and GDP requirements and expectations Participate in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records Reviews completed/executed batch records in support of lot release Compiles supporting data/information for lot release Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API Reviews and approves stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain) Serves as overall back up to other Quality personnel as appropriate LEADERSHIP & BUDGET RESPONSIBILITIES Provides guidance and leadership where appropriate, based upon the results of the documentation review process. Responsible for participating in the budget process for input as required. 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. Knowledge of cGMPs, GDPs, and Corden Quality SOPs, and guidelines as they apply to documentation protocol and validation activities Knowledge of process protocols, batch record requirements, and deviation reporting adequacy Ability to apply attention to detail and regulatory requirements; and a practical, defendable, and logical approach to problem solving EDUCATION and/or EXPERIENCE Bachelor's Degree (BA) from 4-year college or university; or 2 years Pharmaceutical Manufacturing experience in a technical support or production role; or equivalent combination of education and experience. 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. Ability to speak, read, and write in English. MATHEMATICAL SKILLS Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 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, 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 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 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. Knowledgeable of federal and corporate regulations; Chemical Manufacturing; Good Manufacturing Practices and Good Documentation Practices regulations and interpretations Willing to work different shifts Computer related experience Process, computer, and equipment validation experience 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 Maternity/Paternity Leave Tuition Reimbursement Wellness Program Vacation - Three Weeks 1st Year Vision Insurance