Quality Assurance Specialist (Must have a Pharmaceutical or Medical device exp)

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Written by AI from the job title and company, not by Sharp Decisions, so some details may not match this job. The employer's own page has the real description.

Job Overview

As a Quality Assurance Specialist at Sharp Decisions, you will play a crucial role in maintaining the quality and regulatory compliance of our pharmaceutical and medical device products. You will work closely with cross-functional teams to ensure adherence to quality standards and regulatory requirements. The primary focus will be on ensuring that quality assurance processes are effective, which involves evaluating, auditing, and improving operational systems to achieve optimal product quality that meets the needs of our customers and regulatory agencies.

Job Responsibilities

• Develop, implement, and maintain quality assurance processes and procedures in compliance with regulatory standards.
• Conduct regular audits and inspections to ensure adherence to Good Manufacturing Practices (GMP) and ISO standards.
• Assist in the preparation and execution of internal and external audits, responding to findings with appropriate corrective actions.
• Collaborate with product development teams to establish quality metrics and ensure alignment with departmental objectives.
• Review production documentation and batch records for compliance and completeness.
• Identify, analyze, and resolve quality issues utilizing Root Cause Analysis and CAPAs (Corrective and Preventative Actions).
• Provide training and guidance to staff on quality control processes and regulatory requirements.

Qualifications

• Bachelor's degree in a relevant scientific field (e.g., Life Sciences, Engineering).
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Strong knowledge of regulatory guidelines (FDA, ISO 13485) and quality management systems.
• Excellent analytical, problem-solving, and organizational skills.
• Proficient in quality assurance methodologies and tools.
• Exceptional communication skills, both verbal and written, with an ability to work collaboratively.

Technologies & Tools

The Quality Assurance Specialist will utilize a variety of technologies and tools that facilitate quality management and compliance within the organization. This includes software for document control, quality management systems (QMS), electronic data capture systems, and statistical analysis programs. Familiarity with laboratory equipment and validation tools is also beneficial for ensuring rigorous quality standards are met throughout the product lifecycle.

Ideal Candidates

The ideal candidate for the Quality Assurance Specialist role possesses a meticulous attention to detail and a strong commitment to excellence in quality assurance practices. They should be proactive and driven, demonstrating a strong understanding of quality systems and the ability to work under pressure to meet tight deadlines. A collaborative mindset and effective interpersonal skills are essential, as this role requires working with various teams. Moreover, the candidate should have an unyielding commitment to ethical standards and compliance, with a consistent track record of making informed decisions that align with organizational goals.