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Job Summary
The QA associate for documentation ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.
JOB DUTIES & RESPONSIBILITIES
· 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 SupervisorRequirements
Knowledge & Skills
- 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.
Experience & Education
- 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.)
Physical Requirements/Working Environment
- 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.
