Quality Control Technician

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Job Type

Full-time

Description

Job Purpose

The Quality Control (QC) Technician will perform equipment calibrations, 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.

Key Duties and Responsibilities

• Perform QC testing and inspection on all products

• Perform routine laboratory quality control testing, inspections, and analysis of critical items, raw materials, in-process items, and finished goods for all IMMY products.

• 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.

• 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.

• Support laboratory proficiency testing and post-market surveillance testing

• Perform laboratory proficiency testing on IMMY products and document results.

• Maintain end of shelf-life databases including inventory of materials and documentation of results.

• Perform reliability testing of assigned products.

• Perform quality system monitoring and measurement activities

• Perform monthly, quarterly, and yearly calibrations of laboratory equipment (pipettes, balances, microplate readers, etc.) and all required monitoring and measurement testing (bioburdens, residue tests, conductivity, etc.).

• Perform general lab maintenance including maintenance of monitoring equipment (pipettes, multichannels, repeaters, balances, etc.), general lab organization, and lab coat laundering.

• Manufacture QC specimens and reference materials

• Perform testing, manufacturing, and packaging of QC specimens, reference materials, and QC kits.

• Inventory and maintain specimen databases including the check in and check out process of specimens.

• 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; must remain up to date on Quality Regulations and ISO Standards.

• Other duties as assigned.

The Individual

Gets It

• Understands that product meeting specification is what protects the patient and the customer.
• Understands QC's role within the manufacturing process.
• Understands, at a working level, quality standards like FDA 21 CFR 820 and ISO 13485.

Wants It

• Takes ownership and demonstrates enthusiasm in their role.
• Takes ownership of right-first time results and complete, accurate documentation.
• Actively strives to be better and to learn new things as they relate to their role and IMMY.
• Identifies knowledge gaps and proactively works to close those gaps.
• Enjoys precise, repeatable work and takes pride in data integrity.

Capacity To Do It

• High attention to detail and strong organizational skills.
• Comfortable performing repetitive tasks.
• Can handle the stress and pressure of their role.
• Proficient with general laboratory equipment.

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.

Desired Qualifications

• Experience working in a laboratory and use of general lab equipment including pipettes and balances.

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: 3+ 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.