This function is responsible for supporting design control activities.  Functions include device assessments for product complaints, document review, training program support, TrackWise reporting, shift communication and CAPA tracking. This function thresholds events to the Associate Director when they are outside of the area of responsibility.

The position will perform work associated with design control regulations, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations.  Works on problems of a diverse scope where analysis and problem solving is required.  Receives general oversight and guidance on approaches to complete project related tasks.  Applies job related skills and understanding of policies and standards in completing tasks.

Responsibilities:

• Authority to approve written procedures and other documents
• Develop Standard Operating Procedures and other quality related documents.
• Follow-up on preventive and corrective actions associated with deviations and lab investigations Interact with plant personnel to insure CGMP compliance.
• Prepare and maintain batch data tables for trend analysis
• Provides back up for other QA and plant site personnel as appropriate.
• The monitoring of compliance with the requirement of GMP

Qualifications:

• Working knowledge of US Drug Product GMP requirements and associated guidelines.
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Ability to increase others knowledge of US end European GMP regulations and guidance, specifically design controls.
• Strong written and oral communication skills.
• Experience in administration of quality systems for drug product manufacturing and quality control operations.
• Strong written and oral communication skills.

 Personal Attributes:

• Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others
• Good computer skills.
• Good work ethic, dependable, punctual, and flexible.
• Good motivator of personnel.
• Good team player with a can-do attitude.
• Can get things done on the basis of influence.
• Can work in a fast-paced environment with multiple issues open simultaneously.
• Highly organized.
• Attention to detail.
• Identifies opportunities to improve and contributes to problem solving.

 Education:

• Requires an associate’s degree in a scientific discipline or equivalent.

Experience:

• Minimum of 2 years’ experience in the pharmaceutical industry.

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