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For your reference, we have included the original job posting below.
Quality Assurance Specialist (II)
Job Number:
23024390
Company Name:
ISTA Pharmaceuticals
Job Location:
US
Job Category:
Healthcare & Medical
Quality Assurance Specialist (II)
Quality Assurance Specialist (II) Category: QA Description: OVERALL PURPOSE: Support Quality Assurance management in ensuring that operations at ISTA are conducted according to written procedures, regulatory requirements, and guidance documents, as applicable. To include creation, revision, review, and approval of quality-related documents and monitoring of operations both internally and externally. DUTIES & RESPONSIBILITIES: Primary Responsibilities * Review quality-related documents received from other ISTA departments and from external sources, such as contract laboratories and manufacturers, including but not limited to clinical and laboratory data, protocols, reports, Regulatory submissions, calibration documentation, and temperature charts. * Process clinical trial materials (CTMs), including but not limited to creation, review, and revision of labeling materials; execution of labeling protocols; and receiving, inspecting, securing, and reconciling of CTM. * Inspect and release materials, including but not limited to clinical supplies, manufactured products, raw materials, and laboratory supplies. * Create, revise, review, and approve quality-related documents, including procedures, memoranda, protocols, and reports. * Support audit operations, both internal and external, to ensure compliance with applicable procedures, protocols, and regulations, including but not limited to monitoring of quality systems, clinical sites, qualification activities, validation activities, sampling, and testing. Other Responsibilities * Review of executed manufacturing batch records for compliance of manufacturing processes/steps, ensuring that all applicable documents, records and forms are completed and attached, as requested. * Play active role during regulatory inspections, as needed * Miscellaneous departmental activities as required by the needs of the business and determined by QA Management. QUALIFICATION REQUIREMENTS: Knowledge, Skills & Abilities * Experience with working in a Quality function in a cGMP/cGLP/cGCP environment. * Thorough knowledge and understanding of the current Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or International Conference on Harmonization (ICH) guidelines. * Ability to read, develop, and understand procedures and other controlled documents. Good written and verbal communication skills, interpersonal skills, and technical writing skills. * Audit experience (internal or external) is a plus. * Should have the ability to work at a fast pace and handle multiple tasks, work with interruptions, prioritize workload, deal effectively with confidential information, and understand and implement written and verbal instructions. * Must be willing to work late or during weekends, if needed. * Must be able to travel for business, if needed. Additional knowledge and skills preferred:
* Knowledge and understanding of various software packages, specifically Microsoft Office Software (Word, Access, Excel, Outlook, PowerPoint). * Good knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety. * The ability to be flexible and proactive; able to practice good prioritization; maximize efficiency; and have good organizational skills. Education & Experience B.A. or B.S. degree in a scientific field, e.g., chemistry, biology or pharmacology and 2-5 years related work experience. Training Requirements: Training to pertinent quality-related procedures, documents, and methodologies, safety, GMP/GLP/GCP/ICH requirements, and auditing. Physical Demands and Work Environment The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands Standard physical demands; sitting at desk, working at computer. Work Environment Standard office environment, two floors with stairs. ISTA Pharmaceuticals, Inc. offers a competitive package of cash compensation, benefits, work-life programs, and conveniences. Employment is contingent on a successful drug-screening result, and we maintain a smoke-free work environment. We are an equal opportunity employer committed to diversity in the workplace. EOE/AA/M/F/D/V Location Irvine , Minimum Experience (yrs): Required Education: Not Specified Benefits:
