Quality Assurance Specialist

The Senior Quality Assurance Specialist is responsible for working in the Quality Assurance department providing technical knowledge, input, and support for commercial and developmental operations. Support general Quality Assurance related activities while maintaining compliance to the overall Quality Systems of the organization.Provide technical input and assessment for activities related to product development, product design, manufacturing, and packaging operations. Review and analyze data collected through protocols and design documentation against acceptance criteria. Ensure data integrity during data collection and interpretation and ensure proper documentation of data. Write and follow directions provided in SOPs. Familiarity with Federal and regional regulations such as OSHA, FDA, DEA. Review batch records, analytical data, raw material data, equipment calibrations. Provide input for selecting and managing vendors for purchasing. Additional responsibilities will include assisting with vendor qualification, vendor audits, training, and other functions as assigned by department management. REPORTS TO Reports to the Vice President of Quality and will have interactions with members of other departments including Quality Control, Manufacturing, Quality Assurance, Research & Development, Facilities, and outside customers. DUTIES AND RESPONSIBILITIES Provide technical quality support for the validation of laboratory and manufacturing equipment such as stability chambers, HPLC’s, GC’s, filling/packaging, and testing equipment. Technical review and analysis of facility design and validation protocols and related documentation such as utilities, air handling, manufacturing area changes, etc. Independently perform internal and external quality audits. Assist with on-site training. Review and approve validation protocols and validation summary reports. Review and analyze validation data collected through protocols and design documentation against acceptance criteria. Technical review of manufacturing and quality documentation from vendors and management for consensus and approval. Initiates and reviews quality events with minimal supervisory oversight. Work directly with department managers on investigations and CAPAs and reviews/approves OOS investigations and CAPAs. Issue, and review Change Controls (CCs) related to controlled documents. Manage and maintain physical records of technical and quality related documentation, both manually and electronically in accordance with established policies, procedures, and regulatory requirements. Performs batch record review and analytical data packet reviews ensuring compliance with cGMPs and specifications. Perform QA technical document review of Validation, Research & Development, Manufacturing, Analytical and Quality documents. Writes, reviews, and revises SOPs, Protocols, and other company documents as required. Perform in-process and end of process AQL inspections on bottles, cartons, and labels. Provide quality review and disposition raw materials and calibrations. Works under minimal supervision and performs functions that require a degree of creativity, latitude, and independence. Ability to utilize personnel and team resources for GMP related activities. QUALIFICATIONS (Education, Experience, Knowledge, and Skills) Bachelor of Science in Chemistry or Life Science degree preferred. At least 7 years of related experience in the pharmaceutical industry (commercial environment). At least 5 years of food processing experience REQUIRED. Extensive GMP knowledge; Familiarity with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines along with hand-on experience managing regulatory inspections. Must have a strong technical background and thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of Quality related issues. Ability to utilize resources for GMP related activities (manufacturing, deviations, OOS’s). Must be willing to travel, approximately 10-20%. Strong English written and verbal communication skills are required. Ability to interact effectively in a team-based environment. Ability to work independently and work with limited direction. Experience with electronic QMS systems preferred. WORKING CONDITIONS / PHYSICAL REQUIREMENTS Ability to stand for up to 8 hours per day. Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening. Occasional lifting and/or moving up to 25 pounds. LOCATION This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin. Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time. #J-18808-Ljbffr