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Document Control Specialist I
3 weeks ago
The Quality Assurance Document Control Specialist I is responsible for the creation and revision of controlled documents within the organization. This position ensures standards are met and maintained for Standard Operating Procedures, Work Instructions, Methods, and Forms, as well as Raw Material, Bulk, and Finished Goods specifications. Interacts with various departments on the creation and revision of controlled documents. The ideal candidate will demonstrate good document control and technical editing skills, and provide strong support for the timely development, revision, and distribution of controlled documents.
Responsibilities and Essential Duties
- Update specifications into required format and create/update technical sheets within SAGE X3.
- Work with Commercialization for on-boarding new customer specifications and manufacturing processes.
- Assign all document numbers, edit procedures, forms, and specifications, distribute documentation to affected parties, ensure appropriate parties are trained on procedures, and file documentation according to cGMP requirements.
- Ensure compliance with all regulatory documentation standards.
- Create, issue, and file logbooks.
- Ensure all Document Control systems are appropriately maintained and up-to-date.
- Perform periodic audits of the Document Control systems, electronic and paper.
- Assist in cGMP audits by providing documents for auditors and acting as an audit team member in the audit room.
- Assist in the preparation of Annual Product Review projects for OTC products.
- Support Quality Training as needed.
- These responsibilities can and will change as we continue to grow.
- Must possess advanced typing and computer skills, including Microsoft Office software (Word, Excel, PowerPoint).
- Must have advanced skills with Adobe Acrobat or similar PDF file creation software, to include creation of fillable forms and merging documents.
- Experience with document control system software a plus.
- Must possess verbal and communication skill in English.
- Experience with SAGE X3 a plus.
- Must be able to communicate clearly, orally and in writing, and exchange information accurately.
- Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
- Must be self-motivated and possess strong problem-solving and critical thinking skills.
- High School Diploma or equivalent.
- 1 to 3 years of document control experience in a Quality Assurance environment.
- Regularly sit, stand, and walk for extended periods of time.
- Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
- Physically able to lift 50 pounds repeatedly.
- Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
- Prolonged use of computer screen.
- Exposure to repetitive motions (making substantial movements/motions of the wrists, hands, and/or fingers).
