Specialist QA

WE ARE HIRING

Specialist QA

Are you detail-oriented and passionate about ensuring quality at every step of the production process? We are looking for a QA Specialist to support our Quality Assurance operations directly at the plant level. This role is essential to maintaining compliance, ensuring documentation integrity, and driving continuous improvement across our processes and facilities.

Responsibilities:

• Provide on-site QA support to manufacturing and facility operations
• Review and manage GMP documentation, including batch records, SOPs, protocols, and reports
• Participate in the review and approval of production and cleaning processes
• Support and lead investigations related to deviations, non-conformances, and CAPAs
• Draft and execute quality protocols in alignment with internal standards and regulatory requirements
• Assist in environmental and facility monitoring activities
• Ensure compliance with internal procedures and applicable regulatory standards

Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field
• Previous experience in a QA role in a GMP-regulated environment (pharma, biotech, medical device, etc.)
• Strong knowledge of quality systems, documentation control, and regulatory compliance
• Ability to work on-site and collaborate with cross-functional teams
• Excellent attention to detail, organizational, and communication skills

Preferred Qualifications:

• Experience in investigations and root cause analysis
• Familiarity with facility/environmental monitoring programs
• Experience creating or reviewing protocols and technical documentation
• Knowledge of quality tools and systems
• BS Science or related field
• 4 years previous experience within regulated industry.

Job Type: Contract/ On-Site

Available: 1st. Shift

Job Type: Contract

Work Location: In person