Quality Assurance Specialist I

Role Summary

Quality Assurance Specialist I providing support to Manufacturing and Packaging Operations to ensure procedures are followed and meet GMP requirements.

Responsibilities

• Perform packaging line inspections/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.
• Perform other duties as assigned or requested.

Qualifications

• Bachelor's degree is required. Chemistry, medical technology, microbiology preferred.
• Must have experience in a GMP environment, academic or otherwise.
• 1-2 years experience working within Quality Assurance preferred
• Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
• 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 GMPs
• Must be able to work within a team environment
• Must be able to work possible shift changes
• Must be able to travel occasionally

Skills

• GMP knowledge
• QA procedures and compliance
• Documentation and record keeping

Education

• Bachelor‚Äôs degree required; preferred in Chemistry, Medical Technology, or Microbiology