QA Associate - Pharmaceutical Manufacturing

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 Supervisor

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.