Quality Assurance Associate

Sentry Biopharma Services • Indianapolis, IN

428d • $45,000 - $55,000

About The Position

The Quality Assurance Associate is responsible for supporting and implementing Quality Assurance processes, systems, and procedures to ensure compliance with industry standards and regulations. This role involves collaborating with cross-functional teams to drive continuous improvement in product/service quality, resolve quality-related issues, and maintain documentation to meet regulatory requirements.

Requirements

• BA or BS in a science/technical field
• Three (3) years of QA/QC experience in a pharmaceutical, biotech, or other FDA-regulated industry.

Nice To Haves

• Knowledge of GMP regulations and reporting requirements
• Excellent verbal and written skills with all levels of the organization
• Ability to understand basic job functions and relate those to other job categories within the company.

Responsibilities

• Provide daily direct quality oversight of warehouse activities and documentation in compliance with quality system and regulations.
• Perform independent verifications of incoming or outgoing Client material.
• Review warehouse records prior to filing.
• Support Manufacturing Operations by acting as a performer or verifier for labeling and packaging operations.
• Author, review, and/or approve GMP and non-GMP facility records.
• Assist in the authoring, revision, and review of SOPs, COPs, or training material.
• Support internal, Client, and regulatory audits/inspections.
• Participate in Corrective and Preventive Action (CAPA) processes to address audit findings.
• Participate in deviation and investigation reports related to Quality system failures and determine root cause.
• Assist in providing training to staff on quality-related procedures and standards.
• Periodically carry on-call phone and respond to after-hour alarm situations.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree