The QA Specialist is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.. As a QA Specialist -, you will be accountable for identifying trends and reoccurring issues and suggesting solutions:

Key Responsibilities

• Provides daily QA support to warehouse, bulk manufacturing and packaging lines, including workorder evaluation.

• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Review

• Performs or supports activities related Line Audits, Line or Area Cleaning Verifications.

• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).

• Actively supports Site metrics, compliance improvement and training initiatives.

• Provide support to capturing of site metrics and promote improvement opportunities.

• Prepares APR contributions as needed within schedule.

• Generates and examines documentation regularly for inconsistencies, gaps or errors.

• Performs activities to support Destruct Orders and Shipping Orders.

• Supports to maintain documents retention schedule and file completed documents to the applicable areas.