Quality Compliance Specialist
Company: Renaissance LLC
Posted on: November 15, 2022
All 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.
The Quality Compliance Specialist will support Quality Compliance
objectives to ensure compliance to state, federal and other
- 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
- 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
Bachelor'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 preferably
Keywords: Renaissance LLC, Lakewood , Quality Compliance Specialist, Other , Lakewood, New Jersey
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