Senior QA Specialist - Packaging & Labeling

Working in the QA department, you will be working as a Senior Quality Assurance Specialist and overseeing external packaging and labeling CMO's. Working for a global and growing pharmaceutical firm, you will be responsible for adhering to domestic and international GMP regulations, cGMP's, and commercial and clinical packaging.

Responsibilities Include:

Reviewing all quality systems such as SOPs, specifications, Batch Records, deviations, CAPAs and change controls

Conducting reviews of batch records for CMO operations, internal packaging, and labeling operations

Developing compliance of Technical Quality Agreements with the P&L, Component, and Distribution Vendors

Maintaining metrics for routine monitoring and continuous improvement

Responsible for continuous quality improvement and response to quality trends

Requirements Include:

Solid understand of quality systems and cGMP's

Excellent experience with quality systems review and approval such as change control, deviation, and validation

Experience working with supplier organizations, small molecule API and Drug Product, and system/process improvement initiatives

Minimum of 8 years of experience in the manufacturing of drug products, biologics, or devices

Quality experience in finished drug product packaging and labeling

To find out more about Real Staffing please visit www.realstaffing.com