Summary
The Document Control Specialist will manage controlled documents and records throughout the entire lifecycle. They will be responsible for the management and administration of approved documents and training.
Essential Duties and Responsibilities
- Maintaining overall document management system in accordance with Gossamer’s Quality Management Program and all other relevant regulatory requirements.
- Perform various assigned quality assurance tasks, with minimal supervision.
- Learn, understand, and execute various tasks in accordance with company Standard Operating Procedures (SOP) as well as current and regulations, including: GLP, GCP, GMP, and GDPR as they relate to document management systems
- Manage controlled documents and records throughout entire lifecycle: creation, formatting, editing, collaboration, review, approvals, implementation, retention, retirement, and/or archival.
- Ensure proper distribution, organization, and retention of all other Quality Assurance related documents submitted for review
- System troubleshooting for both document and training modules
- Support software upgrades, user functionality and support, simple system configuration, ongoing system improvement, software change management.
- Collaborate in the creation/revision of operational SOPs for the use, maintenance, and security of the EDMS and LMS.
- Manage periodic review of QA Controlled Documents within the EDMS and ensure compliance to SOP requirements
- Development of training content for all system processes, working with QADC team.
- Provide document metrics throughout all lifecycle stages and training.
- Assist with other special projects or other administrative duties, as assigned.
JOB QUALIFICATIONS
Education, Certifications, Experience
- 2-4 years’ experience with document control at a Biotech or Pharma company
- Must have experience in GCP environment with LMS and EDMs
- MasterControl Certification preferred
- Bachelor’s degree in scientific discipline desirable, but not required
- Experience managing quality-controlled documents, revision workflows and document change control processes.
Knowledge, Skills, and Abilities
- Proven ability to establish documentation standards and systems.
- Demonstrated ability to work effectively with cross-functional stakeholders
- Potential to assume increasing responsibilities as the product portfolio and organization expands.
- Excellent organizational, communication and time management skills
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position is $40 to $45/hr. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.
Vaccination Policy:
Gossamer Bio is committed to complying with federal, state and local law on vaccinations. Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at privacy@gossamerbio.com.
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
