Quality Assurance Compliance Specialist
Company: Lynkx Staffing LLC
Location: Saddle Brook
Posted on: February 22, 2026
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Job Description:
Job Description Job Description Quality Assurance Compliance
Specialist Allendale, 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 activities in support of
Quality Systems and/or client procedures, including but not limited
to, document. management: investigations, CAPA, SOPs, qualification
and validation reports, QC data. Supports Quality management with
various department, organizational and operational excellence
initiatives. Generally, exercises independent judgment, within
generally defined practices and policies, when selecting methods
and techniques for obtaining solutions. This role supports internal
and external audits which may include interaction with Health
Authorities and clients. Liaises with relevant functional groups
(Operations, Facilitates, QC, EH&S) to provide guidance through
all stages of the investigation / CAPA processes. Develops and
communicates investigation strategy to key stakeholders. In order
to close investigation and CAPA, collect necessary information from
appropriate department to close in quality system and maintain
investigation and CAPA log Reviews and approves investigations and
CAPAs; Conducts weekly status update meetings with cross functional
departments and other stakeholders. Monitors DR/CAPA KPIs including
reporting requirements, provide detailed updates and information in
support of quality & business review to management on periodic
basis. Prepares and issues change control as necessary. Adherences
and champions to all compliance regulations as required by
regulatory agencies and per the Company’s processes and procedures.
Ensures appropriate CAPAs are generated to increase compliance and
prevent repeat occurrences of deviations. Conducts trend analysis
of compliance related metrics such as deviations and CAPAs.
Performs supplemental investigations and/or participates in project
teams or assignment as necessary. Support in agency, internal
and/or client audits. Functional/Technical Skills: has the
functional and technical knowledge and skills to do the job at a
high level of accomplishment. Decision Quality: Makes good
decisions (without considering how much time it takes) based upon a
mixture of analysis, wisdom, experience, and judgment; most of
his/her solutions and suggestions turn out to be correct and
accurate when judged over time; sought out by others for advice and
solutions. Drive for Results: Can be counted on to exceed goals
successfully; is constantly and consistently one of the top
performers; very bottom-line oriented; steadfastly pushes self and
others for results. Written Communication: Able to write clearly
and succinctly in a variety of communication settings and styles.
Peer Relationships: Quickly find common ground and solve problems
for the good of all; can represent his/her own interests and yet be
fair to other groups; can solve problems with peers with a minimum
of noise; is seen as a team player and is cooperative; easily gains
trust and support of peers; encourages collaboration; can be candid
with peers. REQUIREMENTS BS biological sciences or other relevant
field of study. 5 years’ experience in QA in a life sciences
company with a strong focus in the manufacturing and/or testing of
biologics preferred. Experience in authoring, reviewing, and /or
approving cGMP/cGTP related documents (Investigation report, CAPA
report, SOPs etc.) required. Understanding of quality system
applications, including the use of electronic applications for
training, deviations, CAPA management, etc. Familiar with FDA, ISO,
and other regulatory agency guidelines. Understanding of Good
Manufacturing Practices (GMP), Good Documentation Practices (GDP)
and Good Laboratory Practices (GLP) required. Working knowledge and
technical understanding of aseptic manufacture of biologics
preferred. Experience in both clinical and commercial manufacturing
is preferred. Experience in supporting health authority inspections
and/or client audits preferred. Minimum Required Training
(optional); GXP training, SOP & WI training, Safety Training
Understanding and comprehension of quality system applications.
Working Environment Must be able adaptable, collaborative,
accountable, and have a “can-do” pioneering spirit.Must be able to
work in a team-oriented environment.Must be able to work occasional
weekends, nights, and/or holidays as required/necessary.May be
exposed to infectious diseases transmittable through human blood,
tissues, or bodily fluids.Must be able to handle the standard
moderate noise of the manufacturing facility.Must be able to work
in open floor plan environment and may work in close proximity to
others.Wheel-o-Vator available for use.Small breakroom available.
No on-site cafeteria available.Able to utilize equipment in
manufacturing are as well QC laboratories.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.
Keywords: Lynkx Staffing LLC, Brick , Quality Assurance Compliance Specialist, Science, Research & Development , Saddle Brook, New Jersey
