Quality Assurance Compliance Specialist
Company: Ajilon
Location: Dayton
Posted on: February 25, 2021
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Job Description:
Ajilon is current seeking a full-time permanent Quality
Assurance Compliance Specialist.--Candidate MUST have industry
experience out of generic drug, pharmaceutical or biotechnology
industry. ResponsibilitiesCandidate will be responsible Quality
Assurance Compliance activities, including document management:
investigations, CAPA, SOPs, qualification and validation reports,
QC data. Support Quality management with various department,
organizational and operational excellence initiatives. This role
supports internal and external audits which may include interaction
with Health Authorities and clients.Essential Functions* 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.Qualifications* B.S in
Biological Sciences or other relevant field of study.* Minimum 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.*
Keywords: Ajilon, Trenton , Quality Assurance Compliance Specialist, Other , Dayton, New Jersey
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