Document Control Specialist

Company Background:

GenVivo’s mission is to develop innovative gene therapies to treat cancer and prolong patient survival while improving quality of life. Our approach to synergistically kill tumors while activating the immune system to fight the patient’s cancer combined with the integration of novel companion diagnostics positions us on the cutting edge of cancer immunotherapies and emerging clinical-stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.

General Job Description/Team Overview:

This position is located within the Quality Assurance Department responsible for ensuring adherence to federal and state guidelines relating to good documentation practices and company procedures. The ideal candidate will be responsible for maintaining records and ensuring documents are processed, formatted, issued and made effective accurately. This position assures procedures and forms are deployed timely to functional areas and administers the training program utilizing a computer-based learning management system

Primary Duties and Responsibilities (include but are not limited to):

· Issue batch record documentation, product labels, databooks, satellite files, and other required manufacturing/ quality control documentation.

· Ensure safe and efficient handling and processing of controlled documents and records in accordance with company procedures.

· Route documents and change control forms for approval.

· Control and file all master documents.

· Ensure that only current revisions of controlled documents are available for viewing.

· Organize original documentation into file folders, labeled binders, or other storage locations.

· Scan original files and organize electronic documentation into necessary file name and format.

· Administer the training program utilizing ComplianceWire.

· Maintain site training records for employees and contractors.

· Train document users on Document Control practices.

· Work with functional department heads to establish and review training profiles.

· Develop and produce training metrics for Management.

· Maintain quality system tracking mechanisms, logs, and spreadsheets.

· Coordinate storage, archiving, and retrieval of quality system documents and records with other departments.

· Assist in the document periodic review process.

· Perform projects related to the improvement of quality systems as needed and required by Management.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree or equivalent experience.

· 1-2 years’ experience in Document Control in biotech or related regulated industry.

· Previous experience working within a GMP environment and familiarity with Quality Systems.

· Experience with EDMS and ELMS (preferably, experience with administration of ComplianceWire).

· Must be proficient in basic administrative functions and have advanced skills in the use of office equipment and computer software including but not limited to Microsoft Office applications (Word, Excel, Outlook, etc.), Nuance Power PDF, etc.

· Must have excellent organizational, interpersonal, and communication skills.

· Must be able to work on multiple assignments in collaboration with various department system owners.

· Must exhibit professional integrity and maturity with a high degree of discretion dealing with confidential information.

· Must be able to work as part of a team and independently with minimal supervision.

· Must be extremely detail-oriented, have good time-management and project management skills.

· Self-driven with the ability to excel with minimal supervision.

· Must be willing to perform repetitious tasks such as updating documents, filing, copying, and scanning.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and interpersonal communication skills.

· Eligible to work in the U.S.

Job Type: Full-time

Pay: $55,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Microsoft Office: 1 year (Preferred)
• Document Management: 1 year (Preferred)

Work Location: In person