Quality Assurance Analyst

Job Summary 

The Quality Assurance Analyst is responsible for ensuring cGMP standards are maintained to ensure process and product quality. 

Essential Duties and Responsibilities include the following. Other duties may be assigned.  

• Assist in maintaining Master Batch Record documentation (i.e. new, revision, obsolete, etc.)
• Review Production Batch Record documentation for product release
• Assist in the completion of investigation
• Assist in the implementation of new and revised policies/procedures
• Assist in change control management
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices 
• Perform routine audits of processes and gap analysis relating to production operations
• Perform quality review of documentation and processes
• Ensure cGMP standards are maintained and coordinate efforts to build

Required Education and Experience  

• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field
• 1 years of experience in pharmaceutical/cosmetic manufacturing environment or relevant field, is preferred
• Prior experience in Quality Assurance preferred
• Familiar with GxP, FDA, ICH, OSHA requirements, is preferred
• Experience using Minitab, Excel, and/or relevant applications
• Must have knowledge of basic principles, theories and laws, policies and procedures that pertain to compounding
• Must be capable of wearing all protective wear as required. This includes, but not limited to; mask, gloves, gown, hairnet, safety goggles etc.
• Must be able to work with chemicals used in the preparation of compounds following any special safety precautions as required.
• Must have strong organizational skills and exceptional attention to detail
• Must exhibit punctuality and low absenteeism
• Able to work independently, as well as part of a team

Competencies   

• Communication Proficiency
• Problem Solving/Analysis
• Quality
• Results Driven
• Technical Capacity
• Thoroughness

Work Environment  

This job operates primarily in an office environment. This position requires the use of standard office equipment, and frequent standing and walking.  

Physical Demands  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
• May need to lift up to twenty-five (25) pounds on occasion

Position Type and Expected Hours of Work  

This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Disclaimer  

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.  

AAP/EEO Statement  

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.