Quality Compliance Specialist
Company: Renaissance LLC
Location: Lakewood
Posted on: January 17, 2023
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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 requirements.
ResponsibilitiesPlan, 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% (when travel restrictions are lifted)
QualificationsBachelor's Degree (BA or BS) required, a science
related major preferred. A minimum of four years of related
experience and/or training is required. ASQ CQA & or RAC
certification preferablyPI200403728
Keywords: Renaissance LLC, Lakewood , Quality Compliance Specialist, Other , Lakewood, New Jersey
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