Description
Description:Perform Document Control functions in a manner which support department, and site goals/objectives.
Responsibilities:
- Ensures that all documentation at the site meet the requirements established by local procedures, 9CFR, global regulatory requirements and Quality Standards.
- Ensure continued training on cGMPs, safety, OSHA, technical skills, policies, and procedures.
- Ensure training documentation is accurate and current.
- Assures overall quality/integrity of biological products manufactured and distributed in worldwide markets based on 9CFR, applicable cGMP regulations (EU, JP, etc) and industry standards.
- Maintain a safe and clean work environment. Identify, report and help correct safety hazards.
- Comply with all federal, state and local regulations.
- Make decisions and take actions that are consistent with the highest standards of business and personal ethics.
- Ensure products manufactured by or distributed by Charles City meet applicable EU, USDA, and Company quality standards, as well as the regulatory requirements of a destination country.
- Organize and coordinate initiation, changes, review and approval of specifications, master records, manufacturing directions, outlines of production, and all other related quality records, as needed.
- Control, issue, data entry, scanning, filing and archival of production related documents based on department procedures.
- Organize and coordinate the data acquisition and assist with the compilation of annual reviews of production and quality control records, ensuring scheduled adherence.
- Work with Manufacturing, Quality Control, Information Technologies, and Technical Service Operations personnel to correct deficiencies identified in processes and procedures, either by direct consultation or through assigned teams.
- Maintain excellent working knowledge of all applicable government regulations, regulatory documents, manufacturing/testing processes, and company standard operating procedures.
- Review documentation to verify the accuracy and integrity of manufacturing and testing procedures.
- Participate on key teams and task forces to address quality issues and improvement projects.
- Complete projects assigned by senior department personnel within specified timelines.
Skills/Qualifications:
- B.S in Sciences or related field, or a 2 year degree with 2 years relevant experience, or 4 years relevant experience.
- Minimum of 2 years of broad-base experience working in the pharmaceutical or biologics (vaccine) industry.
- Strong verbal, written and interpersonal communication skills.
- Demonstrated organizational skills, troubleshooting and attention to detail.
- Poultry vaccine or laboratory experience and knowledge of Right First Time principles and tools preferred.
- Strong written and verbal communication skills.
- Demonstrated ability to work with internal and external colleagues.
- This person will need to have computer skills and will spending most of their time scanning completed production records into basic file structures.
- Good data entry skills and ability to understand and work within electronic systems.
- Document Scanning Experience
- MS Word
- Degree preferred, but not required