POSITION TITLE: Document Control Specialist
REPORT TO: Director of Quality
Under general supervision, perform various documentation related activities for a GMP compliant operation applying standard practices, techniques, procedures and criteria as applicable. Ability to accurately scan and save various materials to a controlled database. Use Standard Operating Procedures to maintain an inventory of all manuals, documents, records, SOPs etc. in a GMP compliant document storage area as well as in an electronic database. Maintain an established document tracking, retrieval and archiving system consistent with company and industry requirements. Assist Document Control and the Quality Assurance Units as needed.
- Ensure that appropriate documentation procedures and/or processes are utilized for scanning, filing, tracking, and creating all related company documents without unauthorized modifications.
- Responsible for confirming scanning of all PLI documents and records for production, laboratory, quality assurance, and accounting with extreme accuracy following SOP guidelines. Maintain inventory record of scanned materials in logbooks. Show an effort to continuously improve scanning procedures and accuracy.
- Maintain an efficient and easy to navigate electronic database for scanned materials. Use Adobe Acrobat® features (or other current software) such as “Comments” and “Bookmarks”, to assist users in navigating through various materials.
- Responsible for maintaining maximum security and confidentiality at all times while working with and filing documents and records. Ensure that materials are returned to the document control room/archive area at the end of each day or stored out of site, in a drawer or cabinet in the scanning area.
- Ensure that copies of materials used for scanning and logbooks are shredded regularly. All sensitive confidential information that has a need to be copied, due to poor quality of the original, will be destroyed immediately upon completion of the scan.
- Responsible for creating Quality Assurance logbooks and other bound materials as needed.
- Assist with updating Standard Operating Procedures and other Document Control responsibilities as needed.
- Assist the Quality Assurance Unit on an as needed basis with production and shipping activities.
- Performs other related duties and responsibilities as assigned.
- Bachelor’s degree and a minimum of 4 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
- Have strong knowledge of GMP, SOPs and quality system processes.
- Excellent organizational skills and ability to review processes or procedures.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems.
- Possess strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Experience working in a pharmaceutical or bio-pharmaceutical field.
- Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .