Job Description
Job DescriptionDescription:
Job purpose
The Document Control Specialist is responsible for maintaining the company’s controlled documents system while also ensuring their accuracy, quality and integrity. They will assure adherence to record retention policies, safeguard information and retrieve data as needed in a regulated environment.
Duties and responsibilities
- Perform QA document control function, including document login, tracking, formatting, processing, distributing, and archiving.
- Maintain all controlled document files, both hard copy and electronic versions while maintaining the security controls on all documents.
- Identify and implement improvements to the document control system and maintain departmental databases.
- Perform word processing duties related to writing policies, procedures, and other controlled documents as needed.
- Prepare and write change controls, deviations and CAPA’s.
- Issue and track part numbers for documents, labels, inserts, shippers and boxes.
- Coordinates the revision, review and approval of applicable GMP documents. Responsible for SOP Annual Review.
- Supports in-house training programs including annual training and training files.
- Collects and reports metrics as needed.
- Assists Document Control Supervisor as needed.
Requirements:
Qualifications
Minimum of AA Degree in scientific discipline. Quality experience with minimum 2 years in medical device, pharma or biotech industry. Knowledge working in a regulated environment is desirable. Knowledge of AATB and FDA 1271 GTP regulations is an asset. Recognizing good documentation skills is desirable. Good computer skills including Microsoft Office (strong knowledge of Word and Excel) and Adobe Acrobat. Good verbal and written communication skills. Strong organizational skills; must be detail oriented, have the ability to prioritize, manage time well, multitask and troubleshoot.
Working conditions
Primarily a quiet office oriented work environment. Some evening and weekend work may be required.
Physical requirements
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Direct reports
No direct reports.
Nothing in this job description restricts management’s right to assign or reassign duties and
responsibilities to this job any time