The QC inspector is responsible for inspecting incoming raw materials, sampling, testing physical measurements, and maintaining documentation under GMP guidelines.
Compensation
$30-34.30 an hour W2
Responsibilities
Follow written instructions and specifications under GMP (Good Manufacturing Practices) guidelines
Interaction with the shipping/receiving dept. in the facility warehouse
Inspect all incoming raw material containers; verifies accurate label information, lot numbers and associated paperwork
Responsible for entering sample information into a logbook. Good documentation practices a must
Samples incoming raw materials by physically removing a representative sample from a selected number of containers; detects off-color specification, particle size, appearance, etc.
Execute assigned experimental and process activities in support of defined program deliverables, working under the guidance of senior team members.
Compensation
Pay: $35-38/hr.
Responsibilities
Perform hands-on downstream process operations, such as depth filtration, chromatography, and/or tangential flow filtration (TFF), at both small and large scale.
Support the execution of pilot- and large-scale batches, including equipment and materials preparation, process operation, sampling, and documentation.
Compile, analyze, and summarize experimental data and share results and observations with the team.
Accurately document experimental procedures, observations, and results in accordance with good documentation practices.
Prepare and maintain laboratory equipment, buffers, and materials, and help coordinate laboratory activities and supplies for assigned studies.
The Lead Compounding Technician oversees planning, scheduling, and daily execution for the compounding/manufacture of sterile and non-sterile products in the controlled and classified areas.
Responsibilities
Oversees activities, including but not limited to scheduling, cleaning, preparation of manufacturing hoods to perform compounding activities
Coordinates the working schedules for the compounding teams that are assigned to work as per production schedule
Assist compounders on batch record completion and accuracy of the record
Manage production WIP inside the cleanroom and ensure continue production/product flow
Coach compounders to utilize correct and appropriate aseptic techniques at all times
Requirements
High School diploma or equivalent
Nice to have: Pharmacy Technician (CPhT) License
Nice to have: Certified in ACPE sterile products
Nice to have: Pharmacy compounding
Nice to have: ISO 5/7 environment cleanroom gowning
Execute design verification, reliability, and feasibility testing on the Tablo Hemodialysis System and consumables, record results, and maintain lab equipment.
Compensation
$65,000—$89,000 USD
Responsibilities
Perform design verification, reliability and feasibility testing on the Tablo Hemodialysis System under controlled test protocols.
Collect and record data as instructed in the test protocol, in accordance with Good Documentation Practices (GDP) and data-integrity requirements.
Document test deviations, anomalies, and failures accurately and completely, and escalate them to the responsible engineer in a timely manner.
Operate test and measurement equipment within its calibration period; identify and report out-of-calibration or malfunctioning equipment.
Maintain the lab and test systems in clean and operable condition and keep the lab stocked with consumables and materials required to perform the test.
Requirements
High School Diploma or equivalent
Associates or higher degree in a technical discipline
Nice to have: Associates or higher degree in electrical engineering
Nice to have: Associates or higher degree in computer engineering
Support manufacturing operations for clinical and commercial cell therapy programs through the execution of cGMP‑compliant production activities.
Compensation
The anticipated hourly rate for this position in NJ is $40.86 – $45.67 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs.
Responsibilities
Support manufacturing operations for clinical and commercial cell therapy programs
Coordinate daily production scheduling and resource planning in partnership with Manufacturing leadership
Execute and oversee key manufacturing processes, including cell culture, aseptic processing, cell expansion, separation, counting, and cryopreservation
Assist with the development, review, and maintenance of manufacturing documentation, including SOPs, work instructions, forms, and protocols
Train and mentor Manufacturing Associates in technical operations, aseptic techniques, and cGMP requirements
Requirements
High School Diploma
Associate degree in a scientific, engineering, or biotechnology discipline
Bachelor’s degree in a scientific or engineering discipline
Senior Medical Writer responsible for creating and maintaining clinical evaluation documents for medical devices, ensuring compliance with regulatory standards and internal procedures.
Compensation
Competitive base salary and performance related incentives
Responsibilities
Develop Clinical Evaluation Plans and Reports
Maintain and update existing documentation
Ensure Good Documentation Practices
Review and analyze clinical data
Identify evidence gaps and recommend actions
Requirements
Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field
Perform analytical and physical testing of products manufactured at the facility, monitor quality systems, complete reporting and documentation, and perform general laboratory duties.
Compensation
This position pays a base hourly rate of $25.00 - 27.00 per hour, based on experience with overtime as needed.
Responsibilities
Inspect, evaluate, document, and record finished goods production.
Ensure all specified on-line quality checks are performed properly and on a timely basis.
Document testing, product holds, internal investigations, and root cause analysis.
Issue labels to fulfill production requirements per the Production Schedule.
Review production line parameters and performance for adherence to company Standard Operating Procedures, Quality Guidelines, and Facility Procedures.
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