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QC Analytical Associate (Level 2) Allendale, NJ ref

Company:
ESR Healthcare
Location:
Allendale, NJ
Posted:
January 09, 2021

Posted By Premium Recruiter

Description:

QC Analytical Associate (Level 2)

Allendale, NJ

Direct hire

Skills : QC, microbiology, GMP, CAPA, Flow Cytometry.

About job

Referral reward:$250 Job type:Direct hireJob function:Quality ControlIndustry:BiotechnologyExperience level:AssociateEducation level:Bachelor’s degreeLocation:Allendale, NJZip code:07401Skills:QC, microbiology, GMP, CAPA, Flow CytometryExperience required:1 YearsRelocation assistance:NoVisa requirement:Only US citizens and Greencard holdersclose

QC Analytical Associate (Level 2)

QC Analytical Associate II

The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility.

Essential Functions and Responsibilities

Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate II will include but are not limited to:

Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations

Performs maintenance, monitoring, and troubleshooting of pertinent equipment

Performs and assists in the training of other Quality Control technicians

Maintains training records and coordinates records retention with Document Control and Training groups

Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines

Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable

Participates in managing QC materials and supplies

Performs and assists in equipment and method qualification/validation activities as needed

Performs reagent and media preparation

Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment

Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results

Initiates, investigates, and prepares deviation reports with input from assigned supervisor

Brainstorms and implements corrective and preventive actions, as and when applicable

Documents training and execution of shipping test samples to contract laboratories for testing

Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Communicates effectively with other co-workers, departments, management and clients

Eventually serves as a lead and/or co-lead for client projects

Additional tasks as assigned

Qualifications

BA/BS in a science or relevant field required

Prior cGMP experience required

Prior Flow Cytometry experience required

Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred

Prior industrial experience in cell count methodologies preferred

Prior academic and/or industrial cell therapeutic experience preferred

Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry

Competencies/Candidate Profile

Proficient with computer software such as

Microsoft Office

Visio

Strong written and oral communication skills

Strong presentational skills preferred

Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

Working Environment

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. 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

Must be able to handle the standard/moderate noise of the manufacturing facility

Physical Requirements

The QC Analytical Associate II must be able to work in a laboratory environment for an extended period.

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear

Direct reports / Supervisory Responsibilities

N/A

Other Duties

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.

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