Quality Assurance Technician

Quality Bioresources, Inc. (QBI) provides lyophilization and manufacturing services to clients worldwide. We have more than 30 years of experience in lyophilization of sensitive enzymes, diagnostic products and medical devices. Additional QBI services include powder fills, liquid fills, packaging, labeling and kitting.

With over 26,000 sq. ft. of facility, we have dedicated areas for the following:

• Manufacturing and lyophilization
• Laboratories
• Clean rooms
• Packaging and Labeling
• Shipping and Receiving
• Climate controlled warehousing

Quality Assurance Technician Job Purpose

We are seeking a detail-oriented and experienced Quality Assurance Technician to join our team. The ideal candidate will play a crucial role in ensuring that our products meet the highest quality standards and comply with all relevant regulations. This position requires strong analytical skills, attention to detail, and a solid understanding to quality control processes. The Quality Assurance Technician will work closely with production teams to implement quality systems and maintain compliance with regulations.

Duties

• Perform audits of quality system and production processes.
• Perform line-clearance for process start-up, first article inspection, and verification of process close-out.
• Identify in-process product condition by observation and in-process inspections.
• Verify results of inspections performed by manufacturing personnel and ensure proper labeling and disposition of rejects.
• Verify results of inspections performed by receiving department including raw material and commodity labeling, certificates of analysis, and completion of receiving and inspection documentation.
• Perform water sampling, water testing, particle counts, bioburden sampling, determination of densities, and equipment cleaning verification testing.
• Verify calculations for density, weight checks, formulations and laboratory testing.
• Review batch records, issue certificates of conformance, and release product for shipment to customer.
• Trend data from batch records using Excel spreadsheet, scan and send batch records to customer, and maintain batch record files to ensure ready availability.
• Follow document control procedures to update SOPs and other documents as needed.
• Verify and issue documents and batch records.
• Document and investigate product or process nonconformances.
• Promote and assist with management of the quality system including compliance, training, corrective actions, and process improvements.
• Perform daily temperature checks for incubators and cold/frozen storage units. Replace temperature charts weekly.
• Perform daily inspection of water systems.
• Verify autoclave and depyrogenation oven runs and cleaning of production areas and equipment.
• Provide training including safety meetings and new employee orientation. Facilitate training and ensure awareness of document revisions. Ensure documentation of training.
• Maintain Safety Data Sheet files.
• Maintain a steady and urgent pace while moving freely between departments in order to facilitate production processes.
• Ensure that personnel are performing activities in accordance with written procedures and customer requirements.
• Generate improvement ideas and embrace improvement projects to better the business.
• Perform other duties which may be assigned as part of the essential functions of the position.
• Encourage all employees to engage in safe working behaviors.

Expectations

• Able to follow directions and work with little or no supervision, while contributing to a team effort.
• Must possess good math and people skills.
• Must be able to analyze information and report results.
• Highly detail-orientated and able to audit completion of required paperwork and information system’s inputs with a high degree of accuracy.
• Able to read and understand written instructions and accept verbal direction to successfully complete procedures and assigned tasks.

Qualifications

• BS in Biology, Chemistry or related field
• Organizational skills
• Critical thinking skills
• Verbal/Written communication and presentation skills
• PC skills, including MS Office
• Previous experience in quality assurance is preferred but not required

Job Type: Full-time

Pay: $17.00 - $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person

Salary : $17 - $25