Quality Assurance Analyst (PT) | Sterling, VA

Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.

Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.

Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.

both 21 CFR Part 212 and 211 (as needed) regulations. Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance. Write, review, approve, and implement procedures, specifications, processes, and methods as required.

Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications. Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Ensure that personnel is properly trained and

qualified. Ensure that the training is documented. Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

Liaise with internal and external inspectors and representatives, particularly on QA-related topics. Oversee the metrology program at the site (i. e. equipment, personnel qualifications, validations, etc. ). Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify management problems in personnel, equipment, and the facility that requires correction. Review documents associated with the site's QA program

for completeness, errors, and omissions. A review executed CGMP records and product batch records to ensure compliance and product quality.

Review trends (e. g. environmental monitoring, deviations, facility issues, etc. ) to initiate corrective and preventive actions and/or for continuous process improvement. Conduct a continuous review of aseptic operations to ensure compliance to internal procedures (e. g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc. ) and USP/FDA regulations. Ensure any deviations from normal procedures are documented and justified. Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.

e. follow and maintain corporate CAPA, deviation, and OOS protocols). Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements. Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations. Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.

Attend quality and operational meetings. Interface with Corporate QA and Operations on quality-related issues. Provide status updates as required by management. Other responsibilities as required. Qualifications Bachelor's Degree (B. Sc. preferred. ) Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred. Knowledge of USP, FDA, and c GMP regulations preferred. Knowledge of how and ability to write, review, and revise SOPs required.

Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Ability to write reports, business correspondence, and procedure manuals required. Ability to effectively present information, deliver training and respond to questions from groups of managers, clients, customers, and the general public required. Ability to define problems, collect data, establish facts and draw valid conclusions required.

Ability to solve problems and handle issues required. Proficient in MS Office applications required. Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required. Document Originator & Reviewer Approval Signatures PDN-9acfb3da-3e56-4ace-a40c-8e0edae50918