Duration & Type: 12 months Contract with a major pharmaceutical industry client
Location: Holly Springs, North Carolina
Responsibilities:
- The The QA Engineering Specialist will be a member of the QA Engineering team at the Holly Springs manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations.
- Apply company’s quality principles related to equipment qualification, method validation, process validation, cleaning validation, shipping validation and technology transfers.
- Utilize integrated commissioning and qualification principles to ensure compliance of equipment and system qualification.
- Support the development and maintenance of quality procedures and systems related to Quality Assurance oversight.
- Provide technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.
Required:
- 5+ years of solid relevant QA experience in biotech or pharmaceutical industry
- Excellent knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry
- Education: Bachelor’s degree in scientific discipline/Life Sciences
- Ability to work across time zones and cultures
- Strong influencing and communication skills
- Ability to analyse data to aid implementation of continuous improvements
- Self-motivator with ability to prioritise own workload effectively
For consideration, please send resume to [email protected]
