Job Details

Quality Assurance Specialist IThe role of Quality Assurance Specialist I is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Assurance Specialist I may be involved in all stages of the product life cycle - Product design, manufacturing support, and post-launch maintenance.Key Activities:Participates in efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.Ensures that decisions are made based on sound Quality principles and regulatory guidelines.Management of nonconformances for assigned areas of QA oversight.Assist/perform failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.Execute CAPA effectiveness verifications to confirm that the corrective actions implemented are effective.Trending of key quality metrics, including nonconformances.Preparation of trend reports and presentations for management.Evaluate metrics to identify areas of potential process improvement.Assist in implementation of process improvements.Quality oversight of validation activities for assigned areas of oversight, including QA review and approval of validation documentation.Create and revise quality related documentation.Review and approval of operations records for assigned areas of quality oversight.Qualifications:Bachelor's degree (BA/BS) in life sciences, physical sciences, engineering, or a related field is required.Certifications preferred: CQA, CQE, and CQM.Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing.Familiarity with 21 CFR 210, 211, and/or 820 and ISO 13485.Strong understanding of GMPs and regulated quality systemsExperience with nonconformance investigations and root cause analysis preferredAbility to trend, analyze, and graph data for presentation to managementSpecial Skills:Detail-oriented and well-organizedAbility to multi-task and effectively shift priorities as needed to meet operational requirements and customer demandThis position may be available in the following location(s): US - Greenville, SC (Plant)All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.