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Quality Assurance Specialist

Company: PsychoGenics
Location: Paramus
Posted on: May 16, 2022

Job Description:

About PsychoGenics:
PsychoGenics is a well-established preclinical Contract Research Organization (CRO) that provides comprehensive preclinical testing capabilities in CNS and orphan disorders. PsychoGenics has established several automated behavioral platforms, including the SmartCube platform that provide phenotypic screening at an industrial level to support drug discovery programs.

Overview of Position:
The Quality Assurance (QA) Specialist will help to provide a critical interface between the scientific community, training, and scientific support services. The QA Specialist will report to the VP, QA & Regulatory Affairs and IO, and will serve as a liaison of the IACUC collaboratively guiding and advising research staff to ensure that research and training activities involving animals are performed in accordance with federal, state, local and Institutional requirements. The QA Specialist will assume an administrative, and professional role that will require continuous contact with individuals at all levels of the organization on a variety of complex issues. Integral to this program will be scheduled visits to areas and facilities where these activities occur. The individual is responsible for serving as an adjunct IACUC member and helping to participate in the semiannual inspection process.

Main Responsibilities:
Conducts post-approval monitoring of rodent behavioral and technical procedures in alignment with approved IACUC protocols in an AAALAC International accredited facility.
Conducts in-life QC inspections of study test procedures for compliance and conformance to the approved IACUC protocol, the final study plan, and SOPs.
Performs audits of study specific and facility related documents such as study plans, study raw data, and final report audits for accuracy and completeness, verifying that the final report accurately reflects the raw data generated.
Conducts inspections of facilities, vivarium, and laboratories, evaluating current practices and procedures.
Recommends changes or modifications to vivarium and laboratory procedures to facilitate compliance with PsychoGenics Program Description, IACUC protocols, program methods, and SOPs.
Maintains a current awareness of EPA, FDA, Good Laboratory Practice (GLP) regulations, and any other related NJ state and Federal regulations which may apply to company activities.
Additional responsibilities may also include participating in training activities and assisting with departmental administrative duties as assigned.
Conducts audits of employee training records.
Prepares written records of all inspections and audits.
Reports and submits findings to QA management regarding quality issues and status of inspection and audit activities.
As applicable, submits findings to the principal investigator, the study director, or laboratory supervisor, indicating noncompliance and deviations from Program Description, IACUC protocol, study plan, methods, and SOPs.
Assists in reviewing, writing, and maintaining up-to-date SOPs and controlled documents for the QA unit.
Promotes company polices and operating procedures, to maintain a compliant and safe work environment.
Other duties as assigned by QA management.

Required Qualifications:
Bachelor's degree in Biological Sciences, or related field, with at least 5 years relevant professional experience in animal research specifically rodent behavior, or veterinary medicine, or a Master's degree with at least 2 years work experience.
Knowledge of AAALAC standard, PHS OLAW, and AW regulations, NJ State and Federal regulations governing live animal research. Familiar with EPA, FDA, GLP regulations, and commonly used concepts, practices, and procedures within the QA field specific to preclinical rodent research.
Ability to follow verbal and written instructions, to work under supervision, to work independently with minimal supervision, and to work effectively as a team member.
Focused and well-organized with attention to detail. Ability to multitask and work under pressure of multiple projects and deadlines, to effectively prioritize workload and manage changes in direction.
Must possess the ability to read and understand complex scientific documents such as research protocols, regulations, and policies. Good problem-solving, analytical skills and must work well with numbers. Must be able to record and keep essential records for a regulated environment.
Effective oral and written communication skills, excellent interpersonal and customer service skills including the ability to interact effectively with a diverse constituent population.
Proficient computer skills: working knowledge of MS Office applications, MS Word, Excel, Outlook, database applications, SharePoint, PowerPoint, and Internet.
Ability to function in a fast-paced, high growth work environment, exercise good judgement, and possess a positive attitude.
Must be able to wear appropriate personal protective equipment (PPE), work in a laboratory setting with exposure to chemical and biohazards, work in environments with variable noise levels, and able to stand /sit /walk for extended periods of time.

Preferred Qualifications:
Experience with rodent preclinical research.
Experience with rodent toxicology screening.
Experience working in a GLP regulated research environment.

**At this time, PGI is not sponsoring visas**

Keywords: PsychoGenics, Paterson , Quality Assurance Specialist, Other , Paramus, New Jersey

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