Quality Compliance Specialist
Company: Renaissance LLC
Location: Lakewood
Posted on: June 25, 2022
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Job Description:
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.OverviewThe Quality
Compliance Specialist will support Quality Compliance objectives to
ensure compliance to state, federal and other
requirementsResponsibilities--- Compile data and generate Annual
Product Reviews/Product Quality Reviews. Adhere to timelines
outlined in pertinent standard operating procedures (SOPs) and
communicate due date to respective departments and upper
management. Provide the final report to clients. --- Plan, conduct
and document internal audits. Evaluate findings and report these to
the respective department and upper management. Assure
implementation of any resulting corrective action plans. Use the
internal audit program to assess the level of DPT's compliance with
applicable cGMP, QSR and pertinent standard operating procedures
(SOPs).--- Plan, conduct and document external audits (Raw
Materials, Contract Laboratory, Sterilization facilities, etc.).
Evaluate findings and report these to the respective companies and
Renaissance management. Assure implementation of any resulting
corrective action plans. Use the internal audit program to assess
the level of Renaissance's compliance with applicable cGMP, QSR and
pertinent standard operating procedures (SOPs).--- Assist with
on-site cGMP audits performed by, or on behalf of, clients and
potential clients. Represent Renaissance Quality Systems and
facilitate interactions between clients and Renaissance personnel
during the audit. Assist with management of observations and
corrective actions in Trackwise.--- Manage and prepare client
submission documents retrieved from supporting departments and
assist in responding to deficiency letters received from agency.---
Represent Lakewood Quality Compliance on client conference calls
for submission readiness and support.--- Support upper management
as necessary in preparation for, during and following regulatory
agency inspections.--- Maintain knowledge of cGMP (US/EU) and
company operating procedures and policies.--- Performs other duties
as assigned.--- Is able to travel a minimum of
30%QualificationsBachelor's (B.S.) degree is required, preferably
in a science related field. A minimum of four years related
experience and/or training is required.ASQ CQA & or RAC
certification preferablyPI183221637
Keywords: Renaissance LLC, Lakewood , Quality Compliance Specialist, Other , Lakewood, New Jersey
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