QA Document Control Specialist (Contract)

The Document Control Specialist will assist with the management and improvement of the Learning Management System (LMS) along with employee trainings.  Additionally, this position will be responsible for management of EDMs document routing and trainings administration as it relates to quality/clinical documents and service provider records.

•    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.•    Understand and execute tasks in accordance with company SOPs and current regulations, including: GLP, GCP, GMP, & GDPR as they relate to document management systems•    Perform all onboarding and offboarding activities including live training of new personnel or new system processes.•    Development of training content for all system processes, working with QADC team.•    Provide document metrics throughout all lifecycle stages and training.•    Manage controlled documents & 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 testing, ongoing system improvement, as needed.•    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 periodic review SOP requirements•    Assist with other special projects or other administrative duties, as assigned.

Education, Certifications, Experience•    2-4 years’ experience with document control at a Biotech or Pharma company•    Must have experience in GXP, GMP, GCP environment with LMS and EDMs •    MasterControl certification preferred•    MasterControl experience required•    Bachelor’s degree in scientific discipline desirable, but not required•    Experience managing quality-controlled documents, employee training, and document change control processesKnowledge, Skills, and Abilities•    Proven ability to establish Quality documentation and training materials•    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 skillsGossamer 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 $41 to $45/hr . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  The expected salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below.Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit

Pay Range$41—$45 USD

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.

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 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.

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