Quality Control Technician en IMMY

Description

Job Purpose

The Quality Control (QC) Technician will perform product inspections and assay testing to ensure only high-quality diagnostics are released to IMMY customers. This technician must have a high attention to detail, be extremely organized, handle tight deadlines, and must be comfortable performing repetitive tasks. Under moderate supervision, this technician will perform routine and non-routine laboratory quality control testing, perform stability testing and on-going monitoring of products, and trend quality control data to support the Quality Management System.

Key Duties and Responsibilities

• Perform testing and inspections on all assays including EIAs, LFAs, Foundation products, and MycoDDR
• Conduct routine (QC Testing and Inspections) and non-routine (CAP, NEQAS, proficiency, complaint handling, etc.) laboratory quality control testing and analysis of raw materials, in-process items, and finished goods
• Collaborate with senior team members to interpret test results, compare them to established specifications and control limits, and make recommendations for product release or rejection
• Perform on-going reliability testing of assigned products
• Organize and maintain data generated from quality control testing and ensure that quality documentation and records are compliant with internal requirements as well as applicable regulatory requirements
• Update and trend QC-related data to ensure there have been no shifts in the manufacturing of products
• Ensure all specifications are met during the manufacturing and quality control process
• Perform testing, manufacturing, and packaging of specimens, reference materials, and QC kits
• Inventory and maintain specimen databases including the check in and check out process of specimens
• Perform calibration testing, monitoring and measurement activities, and incoming quality inspections as needed
• Frequent use of Microsoft Office applications, quality management software, and ERP software
• Must comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards
• Remain up to date on Quality Regulations and ISO Standards
• Other duties as assigned

Qualifications and Experience

QC Technician I Required Qualifications:

· Bachelor’s degree in microbiology, biology, biochemistry, chemistry, engineering or related field or a combination of other

education/job related experience

· Skilled in Microsoft Applications including Word and Excel

· Must have professional behavior; excellent verbal, interpersonal, and written communication skills; extremely organized with a

high attention to detail; and able to work independently and as part of a team

· Must be comfortable performing repetitive tasks while maintaining quality

· Experience working in a laboratory and use of general lab equipment including pipettes and balances is a plus

QC Technician II, III Required Qualifications:

· Must meet all requirements of the Quality Control Technician I

· QC Tech II: 1+ years of relevant work experience and/or working in an established ISO 13485 and FDA QSR environment

· QC Tech III: 2+ years of relevant work experience and/or working in an established ISO 13485 and FDA QSR environment

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.