Quality Compliance Sr. Specialist
Company: Renaissance LLC
Posted on: February 22, 2021
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.Overview
The Quality Compliance Sr. Specialist will support Quality
Compliance objectives to ensure compliance to state, federal, and
- 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 Renaissance'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 a any resulting
corrective action plans.
- Assist with on-site cGMP audits performed by, or on behalf of,
clients and potential clients. Represent Renaissance Quality
Systems and facilitate interactions between client and Renaissance
personnel during the audit. Assist with the management of
observations and corrective actions in Trackwise. Prepare or assist
with responding to client observations in accordance with
- Manage and prepare client submission documents retrieved from
- Assist in responding to deficiency letters received from the
- Represent Quality Compliance on client conference calls for
submission readiness and support.
- Complete site reviews of compendia and guidance updates.
- Prepare Annual Product Reviews or Product Quality Reviews for
products produced at the Lakewood site.
- Support upper management in preparation for, during, and
following regulatory agency inspections.
- Prepare and update drug listings for the Lakewood site.
- Work with outside contracting site to maintain
licenses/registrations within each state's requirements.
- Prepare Annual Reports for each state as required and working
with vendor for state licensing. Maintain vendor Licensing Database
- Maintain and knowledge of cGMP (US/EU/Canada) and company
operating procedures and policies.
- Perform other duties as assigned.
- Understand and comply with all Renaissance safety,
environmental and quality practices and procedures as outlined in
organizational/departmental guidelines and SOPs as well as
applicable federal, state and local regulations.
Bachelor's Degree (BA or BS) required. A minimum of six years of
related experience and/or training is required. PI130617764
Keywords: Renaissance LLC, Lakewood , Quality Compliance Sr. Specialist, Other , Lakewood, New Jersey
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