Quality Assurance Specialist I

Job Responsibilities

• Works closely with Global Complaint Lead to manage complaint reports and files.
• Covers coordination with QA, QC, Legal, R&D, and Product Support for SAER and AER investigations.
• Reviews customers and international complaint investigations and provides timely root cause as applicable to enhance consumer satisfaction and safety.
• Reviews batch records, retention of testing data, manufacturing, maintenance, and sanitation records as part of complaint investigations.
• Ensures product complaints and AERs are investigated in a timely manner.
• Provides summaries of issues to Global Complaint Lead for decisions on investigations.
• Ensures all documents associated with an investigation are included in the investigation file.
• Reviews complaint and product return trends to generate weekly, monthly, quarterly, and annual reports on complaint investigation outcomes.
• Identifies if other batches are implicated due to investigations and informs QA management.
• Complies with all regulatory bodies, cGMP, and other requirements and enforces adherence to requirements.

Job Qualifications

• 0-2 years in Quality Assurance experience required.
• BS degree in food science, microbiology, chemistry, biology, or related field preferred.
• Knowledge of business analysis and computer tools: Microsoft Word, Excel, PowerPoint, etc.
• Must have a working understanding of 21 CFR 111; 117; 120 and FSMA.
• Must demonstrate excellent analytical skills.
• Must communicate effectively with all levels of personnel, both internal and external (i.e., suppliers, tech. support, etc.), with excellent interpersonal, verbal, and written skills in English. Bilingual English/Spanish preferred.
• Must possess discretion and judgment.
• Outstanding organizational skills, excellent attention to detail, and the ability to multi-task are required.
• Must be able to work as a team and independently.
• Must be able to work with others to facilitate completing work assignments.
• Must be able to work in a manufacturing environment and travel to contract manufacturing and warehouse locations as needed to complete investigations and inspections.
• Must be able to lift up to 50 lbs.
• Must be able to walk, stand, or sit for 8 hours unaided.
• Must be able to demonstrate ability to detect mm level defects visually, take and give oral instructions in a manufacturing environment.
• Long periods of standing, bending, and repeated lifting (2-5 lbs.) are required.
• Must be able to handle moderate noise level (Must be able to work in manufacturing environments (clean rooms and warehouse)).