Job Description

General job description

We are seeking an experienced and proactive individual to join our Quality Assurance team as a Quality Assurance Analyst II. The successful candidate will demonstrate a moderate understanding of QA principles and their application in a manufacturing setting. This role involves transitioning independently utilizing formal auditing skills, independently drafting forms and SOPs, and taking an active role in training and educating teams on GMPs and quality principles. A QA Analyst II is expected to work with a moderate level of independence, taking on project assignments with support and guidance from QA and other leaders.

SUPERVISORY RESPONSIBILITIES

None

DUTIES AND RESPONSIBILITIES

• Provide quality assurance guidance and support to a variety of business units.
• Conduct thorough data gathering and desk reviews, contributing to data-driven quality assurance.
• Independently draft forms and Standard Operating Procedures (SOPs) in collaboration with other work units.
• Ensure comprehensive and detailed documentation practices.
• Transition to formal auditing skills, including planning, executing, and writing audit reports.
• Train and educate teams on GMPs and the principles of quality.
• Play an active role in fostering a culture of quality within the organization.
• Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.).
• Ensures compliance concerns are prioritized and resources identified.
• Performs review of documents for clarity and compliance.
• Independently perform record review, including batch record review, testing data reviews.
• Work cross-functionally, supporting leaders to accomplish assignments.
• Collaborate with various teams to contribute to a cohesive and effective work environment.
• Understand the quality program and participate in continuous improvement activities including revisions and exploring best practices.
• Receives, tracks, and responds to customer and regulatory complaints.
• Perform effective investigations, audits, Corrective and Preventive Actions (CAPA), and process improvement initiatives.
• Apply creative problem-solving skills within the bounds of regulatory requirements.
• Interprets established procedures and exercises judgment to resolve issues of medium complexity.
• Other job duties as needed.

Education and experience REQUIREMENTS

• A bachelor’s degree in a science related field is required and a minimum of 2 years’ experience in a manufacturing quality assurance role.

Required skills and/or qualifications

• Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
• Exceptional human relations and communication (written, verbal, and listening) skills are required.
• Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
• Strong analytic skills coupled with critical thinking skills are essential in this role.
• Must have demonstrated capacity to comprehend complex protocols, programs, and situations.
• The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
• Willingly work through conflict resolution in a mature and productive manner, contributing to a positive team dynamic.
• Applies professional expertise to contribute to team objectives and outcomes as guided.
• Bachelor’s degree in a relevant field.
• Prior QA experience, in a relevant industry.
• Strong knowledge of QA principles and their application in a manufacturing setting.
• Proven ability to accomplish assignments as directed and work independently.
• Demonstrated skills in formal auditing and project management.
• Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

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