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Form of workJob Description
QA/QC Associate
PURPOSE
Our client, a medical logistics service company, provides temperature sensitive storage, warehousing and rapid distribution services for perishable, biopharmaceutical and medical materials. This Company serves the pharmaceutical, medical and related industries throughout the United States.
Our client is looking for a Quality Assurance professional to serve as its QA/QC Associate at its Las Vegas, Nevada location. The Associate will be responsible for maintaining and overseeing the Companys quality programs in cGMP regulated environment.
RESPONSIBILITIES
Assumes responsibility for supporting cGMP systems and operations.
Interact with regulated departments (Validation group, Inventory Control group, and Operators) to improve current quality programs.
Aid in the creation of SOPs and approving final documents.
Assure all employees are compliant with cGMP regulations. Perform internal audits.
Performs and assigns training to personnel.
Manage the Document Control System.
Reviews and approves deviations, corrective actions, and preventative actions.
Assumes responsibility for maintaining quality programs in cGMP regulated environment.
Perform record reviews/data audits for controlled product.
Review SOPs, records, and related documentation for compliance.
Maintain SOPs, training files, equipment files, deviation files, and change controls.
Assists with the development and implementation of effective Quality Management/Audit strategies.
Aids in preparing an annual plan for auditing all departments and operations.
Aids in coordinating internal auditing programs with those formulated by the Companys independent and regulatory auditors.
Conducts periodic reviews of existing policies to ensure accuracy, efficiency, and effectiveness.
Acts as an internal controls/system consultant.
Ensures that policies and procedures are current and in compliance with evolving regulations, legal requirements, and industry trends.
Knowledge of audit procedures, cGMP and other governmental regulations
Understanding of audit and other related computer applications
EXPERIENCE AND QUALIFICATIONS
Bachelors degree or four years of supervisory or team lead experience in a medical device or pharmaceutical Quality/Regulatory unit
Five years of progressive quality/auditing experience within a medical device or pharmaceutical Quality/Regulatory unit required
Supervisory experience preferred
Industry Certification preferred
