Sr. Document Quality Assurance Associate

This is a hybrid opportunity based out of Concord, California.

Summary & Scope of Position:

The Document Quality Assurance Specialist is responsible for supporting the Cerus document management system, change control process, and customer complaint handling. This role is responsible for reviewing, approving, distributing, and retrieving quality system documents and records. The Document Quality Assurance Specialist will assist in processing customer complaints within the compliant management system, ensuring compliance with regulatory requirements and company policies.

Primary Responsibilities:

• Serve as system administrator for the Cerus electronic document management system; create and update user accounts with the required role/rights within the edms system.
• Maintain and support the document control system for the release, approval, distribution, and obsolescence of quality system documents.
• Support the change control process and updating and reporting the status of change controls within Smartsheet.
• Monitor edms workflow and delegate tasks to team members, facilitate resolution of workflow issues with internal stakeholders.
• Formatting of quality management system documentation.
• Support the periodic review of released documents and ensure compliance with the SOP requirements.
• Support the off-site recordsstorage process: preparenew records for off-site storage, the indexing of the records, and the timely retrieval of records.
• Train users in the use of the edmsand perform additional 1:1 training as required.
• Collaborate with authors and stakeholders to facilitate timely and efficient processing of documentation.
• Accurately enter complaint details into the complaint management system
• Coordinate with cross-functional teams (e.g., Engineering, Manufacturing) to gather necessary information for the complaint investigation.
• Actively seek opportunities for improvement within the department and make recommendations for improvements to the edms workflows, processes and procedures.
• Provide back-up support (with appropriate training) to other roles in the Quality Assurance department as needed.
• Perform related duties as required.

Qualifications/Requirements:

• BA/BS required with a minimum of five years' experience in a regulated industry.
• A minimum 8 years' experience in an FDA regulated document control environment.
• A minimum 2 years' experience using document control EDMS systems such as Agile, Master Control, Trackwise, Veeva, etc.
• Knowledge of quality systems ISO 13485, FDA regulations such as: 21 CFR 820 and FDA Medical Device Single Audit Program (MDSAP)
• Excellent skills relating to Good Documentation Practices and Principles
• Proficiency in Microsoft Word, Excel, Adobe Acrobat DC
• Project management software such as MS Project, Smartsheet, JIRA, Asana strongly desired
• Strong analytical and problem-solving skills
• Excellent time management skills and the ability to multitask effectively, with a commitment to completing work accurately and on time.
• Ability to work with minimal or no supervision

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position in the selected city is $102,000-$120,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.