Quality Assurance Manager

Job DescriptionJob DescriptionOverview: Quality Assurance Manager:

• Design, implement and manage the installation and use of Master Control to handle the electronic documentation of Market Complaint, Deviation, OOS, Outliers, Root Cause Investigation, CAPAs, Recall, Change Controls, SOP and training.
• Chair the Investigations review Board (IRB) meetings, issue minutes and follow up on corrective and preventative actions.
• Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
• Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Manage all CAPA commitments to ensure timely completion of the outlined tasks and effectiveness.
• Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements (i.e. Field Alert Reports (FARs), 3 day and 15 day alerts, etc.).

Qualifications: Quality Assurance Manager:

• BS Chemistry or related science field, MS
• 10 years of experience in the pharmaceutical industry
• Good written and oral communication skills
• Experience in statistical analysis, process capability reviews with software
• Ability to act independently
• Excellent interpersonal, verbal and written communication skills

Benefits Include: Quality Assurance Manager:

• 401(k) with matching
• Health, Vision, Dental Insurance
• Childcare Scholarship
• Tuition Reimbursement
• Bonus Pay + Merit Increases
• Paid Time Off
• Flexible Holidays

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on , veteran status or any other basis protected under federal, state, or local laws.