Quality Specialist, Sterile Manufacturing Job in Charleston, South Carolina US
AAIPharma Services is a leading provider of drug development and manufacturing services to pharmaceutical, biotech and medical device companies around the world. With over thirty years of drug development expertise, we offer exciting and challenging career opportunities in a dynamic and growth oriented business. Our sterile manufacturing facility is located in Charleston, SC, a vibrant city well-known for its coastal beauty, climate, cultural arts, thriving business environment and recent recipient of 1st place honors as the "Most Livable City in America" (US Conference of Mayors). We are currently seeking highly qualified candidates for the following position:
Quality Specialist, Sterile Manufacturing
Performs activities of variety and complexity to ensure quality and compliance with applicable regulatory requirements. This includes reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues in areas of expertise, and maintaining quality databases. Assists with the development of SOPs or other quality documents as needed.
Key Job Responsibilities:
- Performs over sight, quality review and approval of log books, specification, controlled documents, data, protocols, and/or reports.
- Performs quality audits and/or inspections.
- Support document control.
- Maintains quality databases and may perform analysis and trending.
- Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.
- Effectively performs a variety of duties, on schedule, with accuracy and competency.
- Maintains accurate files and records; accurately reports time in applicable time-keeping system.
- Serves as an effective member of the Quality Services team.
- Operations floor support on a as needed basis (may involve 2nd shift)
Qualifications include a BS degree in Chemistry, Biology, or related field with a minimum of one year of related experience. Must have strong teamwork and organizational skills; excellent verbal and written communication skills; ability to multitask and exercise good judgment; be detail oriented with good follow-up skills; and proficiency in computer usage with standard business software
We offer competitive salary, a comprehensive benefits package including relocation assistance, and advancement opportunity.
AAIPharma Services is an Equal Opportunity/Affirmative Action Employer M/F/D/V
