Quality Assurance Specialist I

Quality Assurance Specialist I

Job Description:

We are looking for a dedicated Quality Assurance Specialist I to join our operations team in the field of radiopharmaceutical manufacturing. In this pivotal role, you will be responsible for conducting thorough quality assurance reviews of all drug products manufactured on-site. Your contributions will be critical to the success of high-priority projects that are essential for upcoming clinical trials. You will oversee various operational aspects, including validation and manufacturing processes, while supporting our quality systems functions. This is an excellent opportunity for individuals who are passionate about nuclear medicine research and development and are eager to make a meaningful impact in the Nuclear Medicine landscape.

IT Languages:

• English

As a Quality Assurance Specialist I, you will be engaged in various critical responsibilities aimed at maintaining the highest standards of quality in our manufacturing processes.:

Support quality activities within cGMP operations in a 21 CFR 211 facility;; Initiate and manage Quality Events including Deviations, CAPAs, and Out of Specifications (OOS);; Perform the release of quarantined raw materials and assist in resolving any issues related to material quarantine or rejection;; Review documentation for compliance with GDP and prepare files for archiving;; Conduct real-time reviews of manufacturing batch records to ensure completeness and compliance with cGMP standards;; Maintain and update tracking databases as required;; Assist in training staff on quality procedures and maintain training records;; Review equipment maintenance records to ensure compliance

Spoken Languages:

• English

Skillset:

• Quality Assurance
• GMP Compliance
• Documentation Practices
• Data Analysis
• Problem Solving

Soft Skills:

• Excellent oral and written communication skills
• Strong analytical and critical thinking abilities
• Proven time management skills
• Ability to work independently and effectively under pressure

Qualifications:

• Bachelor's degree in a relevant life science field such as Biology or Chemistry
• Understanding of Good Manufacturing Practices and regulations
• Experience in a FDA regulated manufacturing facility is desirable

Years of Experience:

2

Location:

United States

Job Benefits:

• Comprehensive health insurance
• Retirement plan options
• Opportunities for professional development
• Paid time off and holidays

Working Conditions:

Full Time

Employment Type:

Permanent Contract

Company Culture:

• The company fosters a collaborative and innovative environment where employees are encouraged to share ideas and contribute to the advancement of nuclear medicine. We value diversity and strive to create an inclusive workplace that supports professional growth and development.

Opportunities For Advancement:

• Potential for career growth within the organization, Opportunities to lead projects and initiatives in nuclear medicine, Access to training and development programs

Visa Sponsorship:

Not Available