Document Control & Training Contractor

Position Summary

Reporting to the Executive Director of QA, the Sr. Associate, Document Control & Training will be responsible for administering the Electronic Document Management System and Learning Management System, controlled document processing, assessing document related training requirements and tracking training. The Sr. Associate, Document Control & Training will ensure that document management and training programs are implemented and are effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets. Additionally, this position will establish and modify comprehensive document control systems to be compliant with cGMP, GLP, and GCP requirements.

Primary Responsibilities

• Manage the routine document control and training operations, including (but not limited to) ensuring appropriate document standards are developed and managed, workflows are processed, documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded.

• Manage the electronic systems supporting GxP documents and training.

• Assist with validation of electronic systems and maintain them in a validated state.

• Manage document archive of all internal GxP files.

• Ensure all document control processes and retention of records are compliant with applicable QMS standards.

• Define the policies/procedures for document control processes and company training programs.

• Establish and modify comprehensive document control systems to be compliant with cGMP, GLP, and GCP requirements.

• Liaise with stakeholders regarding document approvals.

• Create performance metrics for Document Control and Training

• Write and revise Document Control and Training SOP’s. Assist with document workflows and processing for all SOPs.

• Train, motivate and guide staff on the Document Control and Training processes.

• Collaborate with Quality Assurance and operational teams to create training content for GxP staff.

• May supervise and or direct the work of outside workers, select site staff, and or professional consultants to deliver training, where needed.

• Other related duties as assigned.

Requirements

• Expected to be on site 2 days per week in the Star Therapeutics office in South San Francisco.

• Experience building and managing document management and training programs.

• Working knowledge of Federal Regulations and Guidance Documents within life sciences industry.

• Team-oriented individual with the ability to effectively work within a team environment.

• Strong attention to detail, able to execute to aggressive timelines

• Excellent verbal and written communication skills.

• Good interpersonal skills with ability to interact with people at all levels with sensitivity and tact.

• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.

• Performs other related duties as assigned.

Education and Professional Experience

• Bachelor's degree required

• Minimum of 3 years of related experience in Pharmaceutical or other regulated industry

• Experience managing electronic and paper quality management systems, document control systems and learning management systems.

• Previous experience in Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations including 21 CFR Part 11 / Annex 11.

Salary Range

The hiring salary range for candidates residing in California for this position is $35 to $43 per hour. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.

• Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.