Quality Lead I

Michigan City, 502 West Highway 20, Michigan City, Indiana, United States of America Job Description What We Offer: We offer a competitive wage and wide array of benefits including: health/dental/vision insurance flex spending accounts short & long-term disability paid holidays and vacation bonuses opportunities (referral, production, etc.) Job Summary: The Quality Lead is responsible for serving as a point of contact for QA Technicians on the shift when other supervision is not available, manage assigned FSQA programs, serve as backup for document specialist reviewer tasks, maintain data entry into associated computer systems as necessary, and work with the QA team and other department personnel to meet requirements, assignments, trials, and responsibilities Hours of Operations: Monday through Friday + Overtime/Weekends 3rd Shift: 9:50PM to 6:00AM Job Duties: Monitor and assist QA Technicians performing in-process QA checks Participate in the Internal Audit program Perform GMP Audits Oversee Incident Report generation and communication Lead and assist in managing RCA-CAPAs Participate in Mock Traces / Recalls as necessary Perform and/or oversee the PEM and Non-PEM swabbing programs Assist in consumer/customer complaint investigations Serve as main QA contact for trials or new product qualification activities as assigned Track and order lab supplies Monitor rework processes when conducted for compliance to standards File paperwork related to the GFSI system Maintain hold inventory records Participate in sensory and other product reviews as required Provide necessary data for KPIs Perform QA Technician duties when required as back up Follow Good Manufacturing Practices (GMPs) at all times Comply with all safety, health and environmental regulations as prescribed by law Comply with all Company rules, regulations and policies May be required to work weekends from time to time Perform other duties as assigned by QA leadership Knowledge of: GFSI and FSMA requirements QA Technician role and responsibilities Customer specs and expectations Exhibited experience with necessary SAP transactions Skill in: Must have excellent oral and written communication skills Strong self-confidence Excellent problem-solving skills and the ability to work with autonomy Must be accurate, detail-oriented and maintain the utmost confidentiality Ability to: Communicate in English to give and acknowledge instructions/problems Physical and mental ability to work in excess of 40 hours per week Add, subtract, multiply and divide in various units of measure, using whole numbers, common fractions and decimals Define problems, collect data, establish facts and draw valid conclusions. Write routine reports and correspondence Interpret a variety of instructions furnished in written, oral, diagram and/or schedule form Work well with others in stressful situations and meet deadlines as necessary Handle multiple priorities and tasks Excellent keyboarding, record keeping and follow-up skills Proficiency in: MS Office Suite and SAP Maintain harmonious working relations with employees from all departments. Maintain harmonious working relations with management from all levels. Communicate effectively with all employees and management. Physical Requirements: Reaching with hands/arms throughout the day. Ability to use hands and fingers. Ability to see, hear and talk. Ability to work in light to moderate noise levels. May be required to walk up to 400 yards to work and break areas. May climb steps to and from work and break areas. May have to work in hot or cold conditions depending on type of production operation Minimum Qualifications: High school diploma or GED equivalent (QAD approval otherwise) Associates Degree in science field preferred, but not required Three – Five years of QA experience in FDA/USDA facilities Experience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP), FSMA (PCQI), and SQF all pluses Sponsorship for work authorization is not available for this position. It is the candidate’s responsibility to ensure they are legally authorized to work in the location to which they apply. Maker's Pride is an Equal Opportunity Employer. Michigan City, 502 West Highway 20, Michigan City, Indiana, United States of America #J-18808-Ljbffr