Manufacturing Associate II

4 weeks ago

Saddle Brook, United States Lynkx Staffing LLC Full time
Job DescriptionJob DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours.
  • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products
  • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety
  • Consistently produce a high level of documentation accuracy and clarity
  • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers
  • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices
  • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints
  • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation.
  • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures
  • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures
  • Notifying Management of any deviation that may occur during processing or during equipment maintenance.
  • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions
  • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner
  • Supports technology transfers into GMP manufacturing operations
  • Participate in the on-call program
REQUIREMENTS
  • BA/BS or Associate's Degree in a biologics or related field preferred
  • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing
  • Current Medical Technologist license or equivalent is a plus
  • Aseptic/cell processing and clean room experience preferred
  • Demonstrates tact and courtesy in dealing with others
  • Strong work ethic, methodical approach to new challenges
  • GLP and GMP experience a plus
  • Must be able to work independently and with minimal supervision
  • Able to work in fast paced environment at times under pressure and with tight deadlines
  • Excellent organizational skills and attention to detail
  • Good verbal and written communication skills
  • Strong team-oriented interpersonal skills are essential
  • Ability to think strategically and tactically (detail-oriented)
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
  • Analytical and problem-solving skills
  • Strong written and oral communication skills
  • Ability to multi-task team is essential
  • Flexible and able to adapt to company growth and evolving responsibilities
  • Ability to work a flexible schedule that may include nights, weekends and/or holidays
  • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill)
  • Must have the ability to work in a team-oriented environment and with clients
  • Must be able to work during the weekend, holidays and as required by the company
Working EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

  • Quality Control Analytical Associate II

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production....

  • Associate Director Manufacturing Operations

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Associate Director, Manufacturing Operations Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet...

  • Associate Director Manufacturing Operations

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet...

  • Manager Manufacturing Operations

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of...

  • QC Microbiology Engineer(s) I, III

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not...

  • Quality Assurance Associate III

    2 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Assurance Associate III Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...

  • Quality Assurance Associate III

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...

  • Quality Control Microbiology Engineer III

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical...

  • Quality Control Manager

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...

  • Quality Assurance Manager

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...

  • Quality Control Manager

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...

  • Quality Control Manager

    2 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...

  • Quality Control Manager

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...

  • Calibration Technician

    1 week ago

    Upper Saddle River, United States Triangle Manufacturing Full time

    Providing Engineering and Manufacturing solutions since 1955, Triangle specializes in the precision engineering and manufacturing of highly complex, tight-tolerance machined parts and assemblies. Triangle continues to thrive in more than 107,000 square feet over four state-of-the-art facilities at our Upper Saddle River, NJ campus. As a family-owned company,...

  • Quality Assurance Compliance Investigator

    1 month ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance...

  • Sr. Facilities Technician

    4 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionSenior Facilities TechnicianAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Senior Facilities Technician position is responsible for performing and documenting the required maintenance and...

  • Housekeeping Associate

    4 weeks ago

    Saddle River, United States Holy Name Medical Center Part time

    Housekeeping Associate - Weekends - Day & Evening Shifts (per diem)Job Title: Housekeeping  Services AssociateDepartment:  Villa Marie ClairePosition Summary:According to established procedures performs a variety of Environmental Services and Hotel Hospitality duties including but not limited to housekeeping, floor care and waste management for the entire...

  • Administrative Assistant II- Accounting

    1 week ago

    Rye Brook, United States Opusing LLC Full time

    Description:Title : Administrative Assistant II- AccountingLocation : Brook, NY 10573 (Hybrid)Duration : 06+ Months Contract (Possibility of extension)Schedule : 8:30 / 9am start - 8 hour daysPay Rate : $25 - $29.83/ Hr. on W2Flexible start: 8:30 / 9am start - 8 hour days Office is on hybrid scheduled: Tuesdays - Thursday onsite, Monday and Friday are...

  • Associate Test Technician

    1 week ago

    Upper Saddle River, United States Mercury Systems Inc. Full time

    Job Summary: Test Technician needed to perform a wide variety of electronic or electro-mechanical assembly tests on Printed Circuit Board assemblies. Must have an understanding of microprocessor and digital theory. Needs to follow methods and sequence of operations in performing tests following Manufacturing Test Procedures (MTP) Job...