Sr. QA Associate

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.

• 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 (Tab Fusion) and off-site records storage (Iron Mountain)
• Serves as overall back up to other Quality personnel as appropriate

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.

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.

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.

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

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.

Ability to read, analyze, and interpret general business periodicals, professional…