Quality Support

Assure compliance with the requirements of 21CFR Part 211 section 211.192 which states that all drug product production and control records shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.  Works closely with the Account Managers, Customer Service, Production, Quality Operations and Warehouse to assure all job-related paperwork complies with regulatory and customer requirements. Supports the Quality System Manager and team by supporting key Quality System Programs, including a selection of the following: Document Control, Change Control, Records Control, Internal and External Audits, Food Safety compliance, Annual Product Reviews, Regulatory Filings, and Continuous Improvement initiatives.

• Perform Acceptance Quality Level (AQL) sampling and evaluation as required to assure product quality
• Assist in ensuring production area is maintained in a state of inspection
• Provides support in the Line Clearance and Cleaning Verification for packaging operations per established Standard Operating Procedures (SOPs) and batch/packaging and labeling records
• Conducts real time (in-process) audits and thorough batch record reviews throughout the production process
• Supports management with a discrepancy or deviation, and provides support to the investigation team
• Provides timely notifications to the customer for incoming quality related issues
• Performs periodic audits of finished product for compliance to customer packaging orders
• Troubleshoot problem areas and apply problem-solving techniques to their resolution
• Monitor quality of incoming and finished product, working towards continuous quality improvement
• Assist in the performance of internal assessments and audits necessary to assure compliance
• Supports and performs incoming Quality inspections and batch record review regularly
• Supports Primary Packaging and Serialization orders
• Serves as mentor/trainer to new Quality members
• Performs certifications for new Quality and Production members
• Assists with Orientation and GDP/Data Integrity training
• First responder problem solver with Quality issues
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions
• Provides assistance and answers questions when needed to Support Staff and Production Staff.
• Instills a sense of quality through modeled quality behaviors and mindset
• Adherence to all Company policies, procedures, cGMPs, and regulatory requirements
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions
• Instills a sense of quality through modeled quality behaviors and mindset
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed

• High school diploma or equivalent required.
• Associates Degree or equivalent combination preferred.
• 4 years plus of similar experience, required.
• In-depth knowledge of governing regulations of packaging, labeling, of pharmaceutical.
• 2-3 years of GDP/GMP experience required.
• The ability to work independently, without supervision required.
• Ability to organize priorities and workload required.
• Ability to work and communicate with cross-functional teams.
• Ability to demonstrate critical thinking.