Quality Specialist

JOB SUMMARY:

Nucleus Biologics™, The Cell Performance Company™, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Our mission is to speed the time from scientific discovery to cure by delivering innovative, transparent and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. We have multiple state-of-the-art facilities where we manufacture our products.

The Quality Specialist supports both quality assurance and document control functions within the Quality Management System. Reporting to the Senior Manager of Quality, this role maintains controlled documents and quality records, issues manufacturing and batch records to support production, coordinates change requests for controlled documentation, reviews batch records and logs in support of product release, and provides support during internal and external audits. The ideal candidate is detail-oriented, comfortable working in a fast-paced cGMP environment, and able to collaborate effectively across functions.

RESPONSIBILITIES:

Document Control

- Support the document control system, including the creation, review, approval, distribution, and archival of controlled documents and quality records.

- Control the distribution of current document revisions to prevent use of obsolete documents, and maintain document retention practices in accordance with company policy and regulatory requirements.

- Execute record archival activities in accordance with company policy and regulatory requirements.

- Issue manufacturing records and associated labeling to support upcoming production needs.

- Issue batch records, logs, and other quality records to support production, testing, and release activities.

- Assign and track training on new and revised controlled documents.

- Serve as Change Request Coordinator, overseeing the creation, editing, and revision of controlled documentation through the change request process.

Quality Assurance

- Review batch records, logs, manufacturing documentation, and associated data for accuracy, completeness, and compliance with established procedures.

- Issue part numbers and validation protocol/document numbers as needed to support quality, production, and validation activities.

- Support raw material and finished goods release activities.

Audit Support

- Provide support during internal audits, customer audits, and regulatory inspections, including audit readiness activities.

- Retrieve and compile documents and records requested during audits and inspections.

Records, Data, and Metrics

- Enter and maintain quality data in the electronic quality management system (eQMS).

- Generate routine reports and key performance indicators, such as document turnaround time, overdue approvals, training compliance, and record status.

- Identify trends and opportunities for process improvement within document control and quality assurance activities.

REQUIREMENTS:

- High school diploma required. Bachelor’s degree in scientific discipline, engineering, quality assurance, or a related field preferred. A combination of education and experience will be considered.

- 2-4 years of experience in quality assurance and/or document control within a cGMP pharmaceutical, biotechnology, or medical device environment.

- Working knowledge of GMP, ISO, and FDA regulatory requirements.

- Experience with electronic quality management systems (eQMS) required;
hands-on experience with ZenQMS highly desired.

- Detail-oriented with a focus on accuracy, completeness, and compliance.

- Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.

- Ability to work effectively in a fast-paced environment, prioritize tasks, and manage multiple assignments simultaneously.

- Ability to exercise independent judgment consistent with Company guidelines.

PHYSICAL REQUIREMENTS:

- Ability to hear and speak to employees and external associates on the phone and in person.

- Ability to see letters and numbers on a personal computer screen and on memos, reports and other documents (near vision).

- Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions.

TRAVEL REQUIREMENTS:

- Limited. May require occasional travel between Nucleus Biologics facilities based on position.

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.