• Maintain physical filing systems for QA documentation, including scanning, filing, archiving, and retrieval of controlled records.
• Issue controlled copies of GMP documents following established document control procedures.
• Support organization and archival activities for controlled documents, logbooks, forms, and training records.
• Ensure accuracy, completeness, and legibility of documents prior to filing or issuance.
• Maintain logs and trackers associated with document issuance and filing activities.
• Assist with the review of documents for formatting and compliance with document control expectations.
• Prepare and organize new GMP logbooks for issuance; collect completed logbooks for archival.
• Support QA team members with routine document control tasks as assigned.
• Escalate issues or discrepancies to QA leadership in a timely and appropriate manner.
• Ensure all activities are performed in accordance with GMP, ALCOA principles, and site Quality procedures.

• High school diploma required; Associate’s or Bachelor’s degree preferred.
• Experience working with Biologics and in a GMP or regulated environment preferred.
• Strong attention to detail and accuracy in handling documents and records.
• Ability to follow written procedures and maintain compliance with document control standards.
• Proficient with Microsoft Office (Word, Excel, Outlook).
• Ability to work independently, stay organized, and manage multiple tasks.
• Strong communication and interpersonal skills.
• Demonstrates professional behavior consistent with company policies and ethical standards.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.