Technical Transfer Technician Job in Charleston 29405, 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).
Technical Transfer Technician
Will be responsible for providing ancillary support to the Technical Services group (including Process and Validation scientists and engineers) for sterile products. This may include preparing process validation and cleaning validation protocols and reports; preparing specifications and manufacturing batch records; reviewing executed manufacturing batch records; preparation, control and issuance of labels and sample submission forms for manufacturing; creating, issuing, and maintaining equipment log books; troubleshooting current validated processes; participating in process deviations and investigations; transferring new process and technologies; participating in manufacturing activities as needed, and writing appropriate documentation to support validation and process transfer activities. These functions will be executed by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices.
Key Job Responsibilities:
• Follow written procedures.
• Clearly and accurately document activities.
• Perform basic math calculations.
• Perform sampling and testing during manufacturing operations, including preparation and control of labels and sample submissions forms.
• Assist in writing batch records, specification, technical transfer documents and validation protocols.
• Preparation, issuance and maintenance of equipment log books.
• Support process validation and cleaning validation efforts.
• Participate in process, equipment and batch investigations and CAPA assignments.
• Provide initial review of executed protocol and batch documentation.
• Interact with clients and auditors as needed.
Qualifications include HS diploma or equivalent with 5-8+ years in pharmaceutical manufacturing environment or equivalent regulated industry. Must have a strong understanding of pharmaceutical manufacturing and packaging of sterile solution pharmaceuticals, applicable SOPs, and safety policies. Requires effective verbal and written communication skills; ability to clearly and concisely document all work activities; strong computer skills; and the ability to work effectively in a team environment.
We offer competitive salary, a comprehensive benefits package and advancement opportunity.
AAIPharma Services is an Equal Opportunity/Affirmative Action Employer M/F/D/V
