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QA Technician - Pharmaceutical Manufacturing
ASCENDING Inc.
Chantilly, VA (On Site)
Full-Time
Description
- Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
- Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
- Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product, label files and change history files.
- Control and issuance of labeling components.
- Manage all document control logbooks and spreadsheets.
- Perform the release of finished product batches packaged.
- Provide new hire training on GMP’s, Safety, and Pharmacovigilance and maintain the training program documentation.
- Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
- Collaborate with team members to ensure timely deliverables for documentation.
- Ensuring all documents are up to date with respect to version control and issuance
- Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints.
- cGMP Compliance in Document Control.
- Any other activity as assigned by the Supervisor
- cGMP compliance within the pharmaceutical manufacturing industry.
- Writing and maintaining cGMP documentation.
- Analyze data/information and resolve complex issues.
- Verbal and written communication skills.
- Work and communicate with cross-functional teams.
- Multiple priorities and re-prioritize tasks.
- At least two (2) years’ experience in a quality assurance role in a cGMP-regulated environment.
- A college Degree preferably in Sciences (i.e. Pharmacy, Biology, Chemistry etc.)
- While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear and use hands and fingers to operate a computer and telephone keyboard.
- Specific vision abilities required by this job include close vision requirements due to computer work.
- Ability to sit at a computer terminal for an extended period of time.
- Light to moderate lifting up to 10-15 lbs. is required.
- Ability to work in a confined area.
Recommended Skills
- Auditing
- Biology
- Change Control
- Communication
- Computer Terminals
- Data Analysis
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Job ID: LI01-10440_3408086444
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