Quality Assurance Manager

Quality Assurance Manager

Compensation: $75-85k (Negotiable based on experience)

Shift: Day Shift

Description:

• A Pharmaceuticals label company Quality Assurance Manager is responsible for overseeing the implementation, maintenance, and continuous improvement of the site Quality Management System and Quality Metrics performance.  Works with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements and ensure sustainable compliance to customer, regulatory and company requirements. Reports directly to the VP of Operations.

Requirements:

• Advanced training or experience in cGMPs, and ISO required.
• Quality Assurance: 5 years
• FDA Regulations and Procedures: 3 years
• Supervisory: 3 years
• CAPA: 3 years
• GMPs: 1 year
• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue..
• Must be able to prioritize and multi-task with minimal supervision.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.
• Excellent written and verbal communication skills.
• Pharma printing experience highly desired

Job Description:

• Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMP’s, as required.
• Ensures that site QMS is in compliance with company QMS requirements, including Quality Task Tracker and Quality Metrics reporting.
• Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820), etc., including preparing for and scheduling annual certification compliance audits.
• Informs site Management of significant or potentially significant quality issues, and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
• Monitors and measures trends in QMS processes, including GMP Quality Metrics.
• Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008, GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data.
• Collects and submits quality task tracker and quality metrics data for the site, on a monthly basis, and issues a report to the Platform Quality Lead
• Interacts with customers and assists with quality related responses to RFP’s/RFI’s for the site.
• Reviews relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
• Leads and manages ongoing internal process verification audits throughout year.
• Provides leadership and direction to quality department employees.
• Ensures all deviation investigations are appropriately investigated and recorded.

Benefits:

• Medical / Dental / Vision Insurance
• Paid Time Off
• 401k with company match
• Disability Insurance
• Life Insurance
• Voluntary Supplemental Insurance
• Tuition Assistance
• Maternity Leave
• Adoption Assistance
• Employer/Partner Discounts