Quality Control Technician

Job Title:

Quality Control Technician

Job Description

This role focuses on supporting the production of biological medical devices derived from porcine liver in a regulated cleanroom manufacturing environment. The Quality Control Technician works hands-on with porcine tissues, prepares and processes materials according to strict procedures, and helps maintain a sterile and compliant workspace. The position offers consistent full-time hours with some overtime, opportunities for advancement to higher technician levels, and the chance to contribute to innovative biotech products within a small, collaborative team.

Responsibilities

+ Work in a cleanroom manufacturing environment to support the creation of biological medical devices derived from porcine liver.

+ Receive porcine livers and verify that incoming materials meet established requirements and documentation standards.

+ Trim porcine livers and prepare tissue samples according to defined specifications and standard operating procedures (SOPs).

+ Scoop, measure, and mix chemical solutions for use with porcine livers, following aseptic and sterile processing techniques.

+ Perform decellularization of porcine livers using established protocols, ensuring consistency and quality in processed tissues.

+ Create, cut, and prepare specific tissue pieces for use in medical devices, maintaining accuracy and attention to detail.

+ Sterilize the cleanroom environment and equipment in accordance with SOPs and good manufacturing practice (GMP) requirements.

+ Follow all SOPs and GMP guidelines to ensure compliance with regulatory and quality standards throughout the production process.

+ Work in the cleanroom during non-build weeks to support assembly activities and related production tasks.

+ Assemble components and materials as needed to support device production and quality control activities.

+ Sweep floors, clean work areas, and perform general housekeeping tasks to maintain a safe, organized, and sterile environment.

+ Update manufacturing records (MFR) and other documentation accurately and in a timely manner to reflect production activities.

+ Support administrative tasks, including order receiving, shipping, and related paperwork, as needed.

+ Assist with sterile processing and sterilization of equipment, materials, and work spaces.

+ Apply aseptic technique consistently when handling tissues, solutions, and equipment.

+ Collaborate with a small team of technicians and partner with the research and development (R&D) team on production and process-related tasks.

+ Work directly with porcine livers during production and assist R&D with porcine kidneys and other tissues during downtime.

+ Stand for extended periods and safely lift bins and livers weighing approximately 5-15 pounds throughout the workday.

+ Adhere to production timelines, ensuring that products move from start to finish according to the established Monday-to-following-Tuesday schedule.

+ Participate in build weeks and non-build weeks, adapting to varying start times, workloads, and mandatory overtime as required.

Essential Skills

+ At least 6 months of experience working within a cleanroom setting.

+ Associate degree in a medical or science field.

+ Experience following SOPs in a GMP (Good Manufacturing Practice) environment.

+ Demonstrated strong attention to detail, including accurate documentation and adherence to procedures.

+ Hands-on experience with cleanroom practices and protocols.

+ Ability to perform sterile processing and apply aseptic technique when handling tissues and solutions.

+

Experience with chemical mixing in a controlled or regulated environment.

+ Ability to perform tissue trimming and handling of biological samples.

+ Knowledge of basic biology concepts relevant to working with animal tissues.

+ Capability to stand for most of the workday and safely lift 5-15 pound bins and livers.

+ Comfort working in a regulated environment with defined timelines and quality standards.

Additional

Skills & Qualifications

+ Associate degree in a scientific field such as biology is preferred.

+ Experience in a laboratory setting working with porcine or other animal tissue is highly beneficial.

+ Background in roles such as butcher, barista, quality technician in the food industry, landscaping, or similar hands-on positions, especially when combined with an outdated or prior scientific degree.

+ Familiarity with cleanroom operations, tissue samples, sterile processing, and aseptic techniques.

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Experience with chemical handling, chemical mixing, and sterilization processes.

+ Ability to follow detailed SOPs and manufacturing records with high accuracy.

+ Interest in working in a biotech environment with opportunities for advancement to Technician II and Technician III levels.

+ Comfort working independently within a smaller team while maintaining strong communication with colleagues and R&D staff.

Work Environment

The role is based in a new biotech facility with a cleanroom that is being built out and expanded. The team will initially…