Job Description

Job Description

Job Description

Quality Assurance Associate – Doc Control

JOB DESCRIPTION:

The ideal candidate can work cohesively and effectively with others to deliver excellence in written/verbal communications, planning, documenting, organizing, and executing multiple tasks simultaneously in a high pace environment. May conduct other quality tasks as required.

Primary Document Control and Label Control Duties:

• Scan batch records, forms, and quality events.
• Perform Document Control Duties
• Store documents in appropriate location on SharePoint.
• Perform Change Management Duties.
• Circulate documents for approval for Change Management Systems.
• Log and track Change Management Documents.
• Modify controlled documents, as required.
• Document actions appropriately following good documentation practices.
• Perform Batch Issuance and Label Control Duties, including printing labels and batch records, and assisting with label reconciliation.
• Perform additional duties as required and assigned.
• Review and approve quality events, as assigned.
• Assist Quality Department during regulatory inspections.
• Create Raw Material Specifications, as assigned.
• Assist with the creation of Finished Product Specifications, as appropriate.
• Document actions appropriately following good documentation practices.

Qualifications:

· Bachelor’s Degree or higher in a life science or related disciple or 3 years GMP experience

· Strong attention to detail

· Knowledge of FDA and USP guidelines

· Excellent oral and written communication skills

· Responsiveness, reliability, ability to express assurance/confidence, professionalism.

· Team-oriented and customer service focused.

· PC skills in Windows-based applications, ability to learn new software.

Confidentiality

The employee must maintain the confidentiality of company information and, pursuant to State and Federal Law (including the Health Insurance Portability and Accountability (HIPAA) Act of 1996), protected health information.

EOE/ADA

Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Carie Boyd Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

We specialize in compounding office-use and personalized prescription medications.

Company Description

We specialize in compounding office-use and personalized prescription medications.

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