Job Title Quality Assurance Engineer I (3rd Shift)
AutoReqId 6425BR
Job Description
Summary: Under general supervision, assists in the generation and review of Annual Product Reviews. Assists in complaint investigations. Audits, monitors and trends assigned work for implementation of corrective and preventative measures.
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Analyzes data from production and laboratories, compiles data for Annual Product Reviews.
• Monitors activities in assigned areas for compliance to standards and opportunities for improvement.
• Coordinates investigations into product complaints.
• Tracks Annual Product Review approval.
• Tracks complaint investigations and follow-up.
• Assists in compiling and generating quarterly and annual quality review documents.
• Researches and recommends improvements in production and laboratory systems.
• Complies with all Company policies and procedures, including safety rules and regulations. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment.
• Performs related duties as assigned.
Qualifications
Knowledge of:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment.
• OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.
• Investigations to determine cause, corrective action and prevention planning.
• Applied cGMP’s and Company systems.
• Laboratory equipment and testing.
• Auditing techniques in a regulated environment.
• Preparation and presentation of Annual Product Reviews (APR’s).
• Compilation of data investigation of Product Complaints.
• Applied statistics and trend analysis.
• Pharmaceutical manufacturing, its customers, competition and market.
• Pharmaceutical manufacturing suppliers, raw materials and products.
• New and emerging inspection and test technology.
• English usage, spelling, grammar and punctuation.
• Engineering and business computer systems and software applications.
Skill in:
• Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Analyzing and troubleshooting problems, identifying solutions, and recommending and implementing methods, procedures, systems and/or techniques for resolution.
• Writing clear and concise technical reports.
• Working with attention to detail, and independently with minimal supervision.
• Managing multiple projects.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining effective working relationships with individuals contacted in the course of work.
• Utilizing a computer and standard business and engineering software.
Education
Minimum Qualifications: Bachelor’s Degree in Science, Engineering or related field from an accredited college or university, and 0-1 year related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience
Shift Night
Department Quality - Site
Location Corona, CA

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