Job Description
POSITION SUMMARY
This position is responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.
POSITION ACCOUNTABILITIES
The following are essential job accountabilities:
• Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
• Perform finished product attribute sample inspection and evaluation of finished products’ physical characteristics prior to packaging.
• Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
• Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
• Assist with maintenance of Supplier Quality program, to potentially include performing external audits.
• Assist as required in the stability department, with validation activities, and/or annual report assembly.
• Perform other duties as assigned or requested.
JOB SPECIFICATIONS
Core Competencies
• Communication
• Continuous Learning
• Customer Service Orientation
• Decision Making
• Integrity
• Teamwork
Functional Competencies
• Analytic Problem-Solving
• Change Leadership
• Data Affinity
• Attention to Detail
• Project and Process Management
• Quality Standards and Best Practices
• Rules and Regulations
Minimum Education
• Bachelor’s degree
Minimum Experience
• 5 years’ experience in Quality Assurance
Minimum Field of Expertise
• Computer skills
• Previous work in a regulated environment
• Problem solving skills
• Ability to coordinate multiple tasks in a fast-paced environment
• Ability to read and follow procedures
• Ability to work independently
• Attention to detail
• Excellent interpersonal skills
• Excellent organizational and follow-through skills
• Excellent written and verbal communication skills
• Knowledge of cGMPs
• Must be able to work within a team environment
• Strong organizational skills
Physical Demands
• Ability to lift up to 20 lbs
Travel
• Occasional travel
Vision Requirements
• Near Acuity: ability to see clearly at 20 inches or less
Supervised: Level
• No supervisory responsibility
Working Conditions
• Possible shift changes
• Typically office environment. Frequent interaction on shop floor also required.