Lead Associate, Quality Control

Job Description
Job Summary
We are looking for Manager / Lead Associate Quality Control to provide support to the Middleburgh site in all Quality Assurance activities. The incumbent will work closely with site Quality Head to maintain all aspects of the site operations are conducted using cGMP methodology as well as follows all current regulatory guidelines.
Responsibilities:
Responsible for supporting management of the Quality System with a focus on continuous improvement and responsibility for ensuring compliance with cGMP, FDA requirements, and internal SOPs.
Manage Reserve sample programs while adhering to internal procedures.
Ensure that Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements.
Ensures all quality stream documents (change controls, deviations, investigations, etc.) are completed thoroughly and by the required due date.
Provide general QA Operations support to site activities with focus on documentation review, generation and approval.
Conduct batch record review and release, change control review and approval, process and analytical investigations, Annual Product Reviews, CAPA follow up etc. related to products manufactured at CPOs to ensure compliance.
Provide guidance to Quality Associates.
Provides data in a timely manner as requested to other departments.
Assists Site Quality Head during audits and inspections.
Be continually aware of current industry trends and regulatory agency interpretation of cGMP requirements.
Responsible to address issues and identify trends that help to ensure compliance, and development and implementation of process improvements.
Ensures data integrity procedures are in place and effective.
Conduct internal audits.