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Jobs at Aprecia Pharmaceuticals, LLC

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QA Analyst - Intern

Mason, Ohio
General Purpose of Position:
This position is primarily responsible for collaborating cross-functionally to support the development and maintenance of quality processes and procedures, and for providing Quality support to operational areas at Aprecia’s Mason facility.

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Develop, maintain, and enhance the Supplier Qualification Tracker and associate dashboard to monitor vendor qualification status, documentation, and requalification timelines.
2 Draft and revise Standard Operating Procedures (under supervision) in accordance with established quality standards.
3 Support Deviation, Corrective Action (CAPA), and Effectiveness Check activities, including maintenance of the Quality Assurance dashboard.
4 Develop and update supplier qualification questionnaires, quality agreements and audit checklists to ensure alignment with current regulatory requirements and industry guidelines (e.g., GMP, ISPE).
5 Assist with the organization, preparation, and archival of quality records, reports and product samples.
6 Maintain, analyze and improve quality metrics to support continuous process improvement.
7 Perform other duties as assigned.

Reporting to this Position:
No direct reports

Travel:
Position may require 5-10% travel

Work Shift:
This position works days

Knowledge, Skills and Abilities:
  • Working knowledge of pharmaceutical industry
  • Strong organizational skills with the ability to manage multiple projects simultaneously.
  • Strong attention to detail
  • Ability to learn and adapt to demands in a fast-paced work environment.
  • Strong written, verbal and interpersonal skills.
  • Ability to work in a hands-on collaborative fashion with many different disciplines both inside and outside of the company.
Education and Experience:
  • Currently enrolled in a Bachelor’s Degree Program in Engineering, Life Science, Business, or related discipline
  • Minimum GPA of 3.0  
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Familiarity with Power BI preferred
  • Able to work FT hours and available throughout the designated program duration
Physical Demands and Work Environment:    
  • Ability to sit at desk for extended periods of time
  • Extended viewing of computer screens and manual dexterity to operate office equipment
  • Ability to perform minimal lifting (typically less than 25 pounds), walking, and physical exertion (bending, kneeling, twisting, climbing) specific to physical inventories and related work
  • Good eyesight and critical thinking to read, create and interpret business documents and spreadsheets
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

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