Document Control and Training Specialist

DOCUMENT CONTROL AND TRAINING SPECIALIST      

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:   

The Document Control Specialist is responsible for the implementation and management of controlled documents in accordance with standard operating procedures and applicable GMP regulations. The role will also include maintenance and support of the quality system.

This position has the potential to be fully remote. Occasional travel may be required for in - person meetings and inspections.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• Maintains a GMP-compliant document management system, to include oversight and auditing of the system.
• Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
• Manages manual electronic signature process .
• Processes cross functional documents, both electronically and hard copy as needed.
• Assists with the set-up and changes in systems, ensuring processes are followed.
• Manages Document Control and Training processes, providing training to personnel as needed.
• Backup for the Complaints and Change Control processes, providing training to personnel as needed.
• Administrator for Document Management System and Training Management System.
• Provides support on various other projects as necessary, ensuring appropriate Document Control is maintained.
• Provides support during inspection activities.
• Other duties as required and necessary to ensure the success of the organization.

QUALIFICATIONS  

• 2+ years of R&D, QA/QC, and/or manufacturing experience preferred.
• BS degree in Science or Engineering preferred
• Working knowledge of GMP requirements, regulations, and guidance
• Experience with document management systems (e.g Box, Sharepoint)
• Knowledge of and skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and electronic document management systems.
• Skilled in effective communication, written and verbal. Ability to effectively present information and respond to questions from internal customers
• Skilled in juggling multiple projects while maintaining attention to detail
• Initiative to jump in and help create solutions to issues found
• Must be able to use individual discretion in completing work assignments, establishing priorities, and working collectively to accomplish deadlines and objectives.
• Working knowledge and understanding of GMPs for pharmaceuticals
• Ability to change direction and respond to new situations which require immediate attention.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 

INTERVIEW INTEGRITY 

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone. 

COMPENSATION AND BENEFITS 

The salary range for this position is $85,000 - $95,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary. 

Please visit https://www.dayonebio.com/benefits to see our competitive benefits. 

DISCLAIMER 

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. 

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief. 

We are unable to sponsor or take over sponsorship of any applicant work visas at this time. 

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.