Eastridge Workforce Solutions is hiring a Document Control Specialist for a neurotechnology company. Our San Francisco, CA, client develops implantable brain–computer interfaces (BCIs). For immediate consideration for this contract role, apply today.

As a key member of the Quality Systems group, the individual will work closely with cross-functional groups to develop and implement efficient and effective GxP compliant document control processes and scale them upward to be software controlled.

Key Responsibilities

• Organize GxP data files into the traceable and trackable system
• Issue and manage data logs for labs, audits, equipment, etc.
• Maintain the archives for GxP studies
• Maintain a working knowledge of FDA CFR requirements (21 CFR 11, 21 CFR 58 and 21 CFR 812) to establish real-time support for GxP operations
• Develop and scale quality assurance document management system and procedures
• Sustain and improve document control quality system towards automation
• Assist in SOP development and revisions
• Backroom lead for FDA/external audits
• Project management and task management
• Negotiating and building relationships with organizations
• Management and oversight of internal and vendors records

Key Qualifications

• Evidence of exceptional ability in organization skills, problem-solving and critical thinking
• 1-3 years of experience in FDA regulated industry
• Strong understanding of Google Suite (Google Documents, Google Sheets, etc.)
• Working knowledge of medical and scientific terminology.
• Demonstrated communication and organizational skills to thrive in a dynamic and cross-functional, fast-paced environment.
• Strong technical writing skills

Preferred Qualifications

• Bachelor's Degree in Administrative field
• Experience in the medical device industry or regulatory affairs
• Prior experience in building or maintaining a document control program and archives

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring, the San Francisco Fair Chance Ordinance, and the Philadelphia Fair Criminal Record Screening Standards Ordinance (a copy of the notice of rights under the Philadelphia Ordinance is available by using this link bit.ly/3WgYFX7).

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