WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation. 

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.

THE OPPORTUNITY

Reporting to the Global Quality organization, the Document Control Associate will be responsible for assisting with the maintenance, archiving and retrieval of all controlled documents and records required by applicable regulatory requirements. The Document Control Associate may assist in the development and preparation of such documents and records and tracking action items for other quality processes.

WHAT YOU WILL CONTRIBUTE

• Document management knowledge: including ability to organize documents for distribution, traceability, retrieval, and archiving (digitize document); all consistent with contract requirements and workflow procedures.
• Manages controlled documentation through the document lifecycle and compliance with applicable procedures and regulatory requirements.
• Collaborates with Business Owners to ensure document changes and training requirements impact assessment are effectively managed to meet timelines.
• Work with other departments to clarify and correct documentation to ensure compliance and maintain good communication.
• Organize and maintain the work area and keep up to date files.
• Support process improvement projects, as assigned.

WHAT WE SEEK

Experience Required:

• Minimum two (2) years’ experience in a document control, or similar, office environment, preferably with knowledge and experience in a highly regulated or FDA environment.

Specialized or Technical Knowledge, Licenses, Certifications needed: 

Planning & Organizational:

• Ability to think critically and creatively; have great attention to details.
• Have strong organizational and planning skills.
• Able to work independently and collectively as part of an integrated team environment 
• Comfortable working in a highly innovative environment and strong ability to cope with change.
• Plans periodic review of SOPs and other procedural documents using a risk-based approach.
• Assesses gaps in existing SOPs; plans updates and implementation in accordance with applicable regulatory requirements and corporate goals.
• Develops workable action plans for streamlining and implementation of activities, thereby reducing cycle time and increasing efficiency.

Interpersonal 

• Excellent communication skills when communicating with management, colleagues, peers, and management of other departments, third parties, and regulatory agencies.
• Must be friendly and possess good interpersonal skills. Sets expectations and monitors delegated activities.
• Shows respect and sensitivity for cultural differences.
• Treats people with respect; keeps commitments; works ethically and with integrity; upholds organizational values.
• Must be a team player.
• Must be very meticulous, well-organized and pays attention to detail.
• Must be able to work with changing priorities. Sets expectations and monitors delegated activities.

EDUCATION

• Requires high school education or GED. 1-2 years of college or technical school, preferred.
• Education Required: Requires high school education or GED. 1-2 years of college or technical school, preferred.

WHAT WE OFFER

An exciting opportunity to join a company that offers:

• Catered lunches
• Free variety of snacks and beverages
• Referral Bonuses
• On Campus Gym 
• Company sponsored FUN events

The anticipated salary range for candidates who will work in San Diego is $27.00 to $30.00 per hour. 

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is multi state employer and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. 

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com

Arcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.