What are the responsibilities and job description for the Specimens Processing Technician (Clean Room/Aseptic Processes/GMP) position at Systems Ally?
First shift schedule with flexibility (7am-3:30pm).
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.
- The Process Development Tech II serves as a subject matter expert and ensures the continuous flow of processing activities.
- 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 has the ability to use fine motor skills to operate equipment and/or machinery.
- Attention to detail is necessary when testing, assessing, and processing tissue samples.
- In addition, the 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 room and non-climate-controlled environments.
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE: % of Time or Importance
- Precisely follow company tissue requests, study designs, protocols and SOP’s for the complete processing of tissue based products. 40
- Perform lab testing to demonstrate the ability of the product/device to function as intended (i.e. verification and validation of process). 15
- Assist in the development of processes for manufacturing and commercial tissue products. 5
- Work with the in-house manufacturing group to scale-up, validate, and transfer the commercial manufacturing process. 5
- Monitor the performance of processes and equipment and make recommendations for continuous improvement. 10
- 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
Years of experience/education and/or certifications required:
- Associate’s degree w/ 3-5 years of experience
What are the top 3-5 skills requirements should this person have?
- Excellent interpersonal skills to allow effective participation with project teams
- Understanding of Quality System Regulations (QSR)
- Ability to lift 25 pounds
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- 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
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
- Quality/ R&D experience
What type of environment is this person working in?
- Process Lab Environment – working with industrial machinery – processing at a higher level. Not Mfg, but not test tube.
Job Type: Contract
Pay: $23.00 - $25.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- Cleanroom: 3 years (Preferred)
- CGMP: 3 years (Preferred)
- aseptic processes: 3 years (Preferred)
- development of tissue based products: 3 years (Preferred)
- using mfg equipment for the medical device industry: 3 years (Preferred)
Ability to Commute:
- Branchburg, NJ 08853 (Required)
Work Location: In person
Salary : $23 - $25
