What are the responsibilities and job description for the Document Control Specialist position at PL Developments?
JOB QUALIFICATIONS:
- Associate Degree or Bachelor’s Degree Preferred.
- Must have three years minimum of experience working in a regulated industry.
- Must be an effective communicator and understand written procedures.
- Knowledgeable in cGMPs and FDA regulations.
- Planning and organization; and ability to plan and manage multiple projects.
- Attention to detail.
- Excellent interpersonal and communication skills.
- High performance team and strong team player.
- Ability to follow routine verbal or written instructions.
- Computer proficiency: Word, Excel and Power Point.
- Able to work under pressure and meet deadlines.
- Able to work with minimal supervision.
POSITION RESPONSIBILITIES:
- Prepare, update, maintain and upload in the ERP system the Master Manufacturing Records.
- Update and maintain the Enterprise Resource Planning (ERP) on tasks related to Quality Assurance Specifications and Product.
- Issue to production department with all documents (BR, Forms, logbooks etc.) requested to complete the production schedule on time.
- Prepare, update and maintain other documents needed for the QA Department.
- Works on special projects assigned by the Manager of Quality Assurance
- Assists with issuance, review, revision, and archiving of all quality documentation.
- Assist with managing and tracking, change control, specifications, validation protocols/report, work instruction and Deviations/investigation in agile.
- Locate, and update database for documents requested by Validation, Audits and Manufacturing (COA, BRs, AQLs, Reports).
- Receiving, filing and log in original documents, Chart records, executed BRs, logbooks.
- Run Oracle reports for completed training and approve all CRNs requested by system notification.
- Updating format and reviewing of the current procedure for overdue documents and creating the CRNs to facilitate their approval.
- Create and send Issuance of notification for BR, WI, SOP and Validation Protocol
PHYSICAL REQUIRMENTS:
- Complies with all Company policies and procedures, including safety rules and regulations
- Work is performed in a standard office environment
- Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds
