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Document Control Associate

4 months ago

San Diego, United States Arcturus Therapeutics Inc Full time

**WHY WORK FOR ARCTURUS?**

**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:

- Exceptional organizational skills. Must have a keen eye for detail for proofreading and auditing tasks. Must be able to follow instructions and work independently with mínimal supervision.
- Familiar with Microsoft Office. In-depth knowledge of Microsoft Word and Excel. (i.e. Creation and maintenance of Word documents, templates and forms).
- The ability to multi-task, work against and to an established schedule and/or deadline.
- Good computer skills and ability to learn new software and databases.
- Ability to work in electronic document management system software.

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

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.