Lab Tech II

Spectraforce Technologies, Inc.; Branchburg Township (NJ); On-site; USD 42,000 - 66,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Lab Tech II for our Branchburg, NJ site to support processing of tissue-based products. The role requires clean room gowning, lab testing, and working onsite in a GMP/QA environment.

First shift 7am-3:30pm with some flexibility, assignment duration six months with possible extension. The successful candidate will handle equipment such as heat sealers and laminar flow hoods, document batch records, and train junior staff while ensuring safety and

Qualifications

• Associate degree with 3-5 years lab experience in tissue processing.
• Understand Quality System Regulations (QSR) and GMP/GDP expectations.
• Able to lift up to 25 pounds and operate lab equipment safely.
• Experience with tissue-based product development is advantageous.
• Follows SOPs, work instructions, and maintains accurate records.

Responsibilities

• Follow tissue requests, study designs, protocols and SOPs for processing tissue products.
• Perform lab testing to verify product/device function and reliability.
• Assist in process development for manufacturing tissue products.
• Collaborate with manufacturing to scale-up and transfer processes.
• Monitor process and equipment performance; suggest improvements.
• Serve as SME, guide junior staff and train new employees.
• Operate heat sealers, laminar flow hoods, aspiration systems, scales, shakers and equipment.
• Record batch records, equipment and cleaning logs; maintain documents.
• Maintain inventory of processing supplies and enter data into systems.

Skills

Interpersonal skills

QSR knowledge

Aseptic processes

GDP/GMP familiarity

Process development

Education

Associate's degree with 3-5 years experience

Job description

Position Title: Lab Tech II

Work Location: Branchburg, NJ 08876

Assignment Duration: 06 Months (possible extension)

Work Schedule: First shift schedule with flexibility (7am-3:30pm)

Work Arrangement: Onsite

Position Summary:

The Process Development Tech II position exists for the processing of human, porcine and fat-based tissue products. It requires clean room gowning and working in a lab setting. Process Development Tech II serves as a subject matter expert and ensures the continuous flow of processing activities.

Background & Context:

It requires lifting to 30 pounds of boxes and materials off racks. The position involves frequently sitting, walking, reaching, stooping, squatting, crouching, kneeling, crawling and stair climbing and can use fine motor skills to operate equipment and/or machinery. Attention to detail is necessary when testing, assessing, and processing tissue samples. In addition, Process Development Tech II requires the ability to comprehend work instructions and safety requirements to enter information into work logs and existing computer systems. Finally, the position requires the ability to work with solvents, cleaners and disinfecting products in both clean rooms and non-climate-controlled environments.

Key Responsibilities:

• Precisely follow company tissue requests, study designs, protocols and SOPs for the complete processing of tissue based products
• Perform lab testing to demonstrate the ability of the product/device to function as intended (i.e. verification and validation of process)
• Assist in the development of processes for manufacturing and commercial tissue products
• Work with the in-house manufacturing group to scale-up, validate, and transfer the commercial manufacturing process
• Monitor the performance of processes and equipment and make recommendations for continuous improvement
• Serve as a subject matter expert, provide guidance to junior staff
• Train new employees
• Operates heat sealers, biohazard laminar flow hoods, aspiration systems, weighing scales, orbital shakers, splitter, grinder, gerber table, mixers
• Records information on batch records, equipment and cleaning logs, and other documents
• Maintains inventory of processing supplies
• Uses computers to enter data and generate reports

Qualifications & Experience:

• Associate's degree w/ 3-5 years of experience
• Excellent interpersonal skills to allow effective participation with project teams
• Understanding of Quality System Regulations (QSR)
• Ability to lift 25 pounds
• Prior experience with using manufacturing equipment for the medical device industry
• Prior experience in development of tissue based products is a big plus
• Prior experience in aseptic processes
• Prior experience and understanding of GDP, and GMP