Job description

Quality Assurance Operations Specialist will primarily be responsible for supporting late phase and commercial quality operations’ activities. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization through providing quality oversight on exception documents such as Deviations, CAPAs and Change Controls

• Actively participate in fostering a positive, collaborative work culture
• Ensuring adherence to cGMPs across the organization
• Collaborate with other departments to ensure timely closure of investigation activities including Deviations, Lab Investigations and OOSs
• Collaborate with other departments to ensure timely initiation and closure of CAPAs and Change Controls
• Participate in customer meetings as needed to drive customer review and approval on exception documents
• Foster and develop intra- and inter-departmental relationships
• Support product disposition activities
• Provide support for internal and external audits including report generation
• Evaluate and mitigate program risk and escalate quality issues as needed
• Support quarterly quality management review meetings through preparing metrics

Job Type: Full-time

Pay: $30.00 - $45.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• No weekends

Education:

• Bachelor's (Required)

Experience:

• Quality Assurance: 2 years (Required)
• VEEVA: 2 years (Preferred)

Work Location: One location

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