RIM Recruitment Professionalshttps://www.rimrp.com/wp-content/uploads/2022/08/rim-200x200-1.pnghttps://www.rimrp.comhttps://www.rimrp.comUSD78000.00YEARtrue
Job Summary: We are seeking a Quality Assurance Specialist to support the Quality Assurance department in ensuring compliance with quality and regulatory standards. The successful candidate will work closely with internal teams and external partners to implement quality systems and maintain regulatory compliance in a fast-paced, highly regulated environment. This role is a generalist role rather than a specialist.
Key Responsibilities:
Assist in the development, implementation, and maintenance of Quality and Regulatory Compliance strategies.
Support site readiness for internal and external inspections, including audits by regulatory bodies such as the FDA.
Collaborate with manufacturing partners, logistics providers, and other external stakeholders to manage quality-related processes.
Support the roll-out and ongoing management of quality systems and tools.
Perform quality-related tasks, including documentation, quality assurance agreements, audit participation, and complaint management.
Manage and maintain compliance-related records, including recalls and mock recall procedures.
Draft, review, and update Standard Operating Procedures (SOPs) and other quality documentation.
Participate in and support internal and external audits, ensuring all required follow-up actions are completed.
Execute system transactions using SAP or other relevant software as needed.
Qualifications:
Minimum of 2 years of experience in a regulated environment (e.G., GMP, FDA, EPA).
Working knowledge of FDA regulations (21 CFR Part 820) and EPA standards for antimicrobial products.
Bachelor's degree in life sciences, engineering, or a related field is preferred.
Familiarity with medical device regulations and ISO standards (ISO 13485) is advantageous.
Strong communication and documentation skills, with proficiency in Word, Excel, and PowerPoint.
Experience with quality management systems (e.G., SAP, TrackWise) is a plus.
Ability to manage multiple priorities in a dynamic, team-oriented environment.
A proactive mindset with a focus on problem-solving, decision-making, and continuous improvement.
Desired Traits:
Strong organizational and time management skills.
Adaptability and openness to diverse perspectives.
Ability to handle increasing responsibilities and larger projects over time.
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