Document Control Specialist - Contract

POSITION SUMMARY: Precigen is advancing an exciting pipeline of novel cell and gene therapy products, and to further our efforts we are seeking a highly motivated and skilled Contract Document Control Specialist with strong organization skills and attention to detail to work with our Quality Assurance team. This position will be responsible for the daily operations of issuing, reconciling, filing, etc. of controlled documents and records in accordance and compliance with Precigen’s Quality Systems, GxP regulations, and company procedures/policies. Position is for approximately 6 months. DUTIES AND RESPONSIBILITIES: Execute the daily functions of the document control process including but not limited to: formatting documents, tracking documents through the review/approval cycle, issuing documents for execution, reconciliation of issued records, and archiving. Assign training to employees per established curriculums; maintain the training database and training files. Scan, organize, maintain, and file documents, adhering to the company's document lifecycle procedures. Includes both paper-based and electronic filing. Support overall QA functions; perform additional duties as assigned by supervisor. EDUCATION AND EXPERIENCE: High School Degree or GED equivalent Minimum two (2) years of experience in a regulated work environment. Experience with document control systems; experience with EDMS is a plus. Experience working within a GxP pharma/biologic environment is a plus. DESIRED KEY COMPETENCIES: Ability to understand and execute on the company’s mission and values. Exceptional organization skills with strong attention to detail. Strong interpersonal skills including clear communication in both oral and written form. Demonstrated ability to work with and coordinate demands from multiple stakeholders. Exhibition of the highest degree of ethical standards and trustworthiness. Strong understanding and use of Microsoft Office Suite and Adobe Acrobat Pro. Responsive, can-do attitude. Deals with conflict in a direct, positive manner. Ability to think and adapt to a rapidly changing environment and demands. WORK ENVIRONMENT: Administrative office/cubical; minimal laboratory access Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus. Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/ or move up to 30lbs. General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.