Quality Analyst

$52,000 - $72,800/Yr

Computech Corporation - Mason, OH

Part-time - Mid Level

Mason, OH

Professional, Scientific, and Technical Services

About the position

The Quality Analyst at Computech Corporation plays a vital role in the Quality Assurance department, focusing on the review and approval of executed batch records from external business partners. This position ensures compliance with internal standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory requirements. The ideal candidate will have a strong understanding of Good Documentation Practices (GDP) and will be adept at managing multiple priorities in a fast-paced environment.

Responsibilities

• Conduct comprehensive reviews of batch records for accuracy, completeness, and compliance with GMP and GDP standards.
• Ensure all required documentation is present, including production records, equipment cleaning logs, and quality control results.
• Identify and escalate discrepancies or deviations in batch records for timely resolution.
• Promote Good Documentation Practices throughout the organization and identify areas for improvement.
• Collaborate with cross-functional teams to facilitate efficient batch record review processes.
• Communicate effectively with team members and management regarding batch record issues and compliance challenges.
• Manage and prioritize multiple batch record reviews to ensure timely product release according to production schedules.

Requirements

• 2 years of experience in Pharmaceutical Manufacturing.
• 2 years of experience with batch records.
• Strong understanding of Good Documentation Practices (GDP).
• Exceptional attention to detail.
• Effective communication skills.
• Strong time management and organizational skills.

Nice-to-haves

• Ability to balance time-based priorities.
• Advanced organizational and time management skills.
• Strong communicator.

Benefits

• Health insurance
• Dental insurance
• Vision insurance