Quality Assurance Administrative Specialist

Job Title: Quality Assurance Administrative Specialist

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Westfield, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Administrative Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. This position is responsible for ensuring the efficient management of controlled documentation, quality records, training records, and administrative quality system activities. You will serve as a key coordinator for QA documentation and records management, compliance with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Parts 210 and 211), and applicable EU GMP requirements. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

• Management of a document control process for a cGMP manufacturing site.
• Support the creation, formatting and approval of standard operating procedures, forms, and templates.
• Creation and implementation of hard-copy and electronic filing systems for GMP drug manufacturing, including maintaining critical quality documents on and off site.
• Support of GMP manufacturing processes, such as with release of incoming raw materials and issuance of batch records and test records.
• Creation and maintenance of various document templates and databases.
• Actively track and manage on-time record closure for critical records at the site.
• Support the ongoing development and improvement of the quality management system (QMS).
• Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Agency, Food and Drug Administration, etc).
• Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.

Requirements

Education and Skills:

• A minimum of an A.S. degree in the life sciences or business administration is required. B.S. degree is preferred.
• Extensive experience and confirmed high-level competence with MS Word, Excel, and PowerPoint is required.
• 3+ years working in a quality control or quality assurance position supporting GMP manufacturing is preferred.
• Experience working in pharmaceutical or other regulated environments preferred.
• Strong understanding of cGMP requirements is preferred.
• Detail-oriented mindset with excellent organizational and record-keeping skills.
• Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
• Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
• Flexibility to work in shifts and handle time-sensitive processes.
• Strong commitment to safety, ethical conduct, and compliance with regulations.

Benefits

We offer a competitive salary, a comprehensive benefits package and advancement opportunity.

As an Equal Opportunity Employer, we are committed to a diverse workforce.