Are you looking for a job that will help you assist in ending the COVID-19 pandemic? We have partnered with an industry leading bio-pharmaceutical manufacture that is ramping up production for a Corona Virus vaccine. This Albuquerque, NM based sight is seeking to increase its headcount by 100 individuals over the course of the next year to keep up with production! As a part of the first wave of growth my client is seeking a talented Manufacturing QA Specialist to join its rapidly expanding team.
The Manufacturing QA Specialist will have the following responsibilities:
- Performing line clearances and line monitoring
- Able to work effectively with other departments, coworkers, and QA teams Being proficient at technically reviewing/auditing shop floor records and reports such as logbooks and other types of documentation for completeness and accuracy
- Assisting other MQA Specialists or MQA Sr. Manager to identify technical problems and provide guidance and support to real time shop floor quality issues up to and including: making real time product impact assessments, and go no go decisions
- Participating in quality systems implementation and maintenance efforts.
- Awareness of changes impacting internal SOPs, recommending modifications for SOPs and author, review and edit documents, protocols, and problem reports
- Evaluate deviations related to production batches, the laboratories, or the facility
- Working with the QA Product Specialists to support customer issues, investigations, corrective actions and change controls QA operates 24 hours a day, 5 days a week for production support
- Responsible for performing and providing QA leadership for the Business Units.
- Represent MQA leadership on shift to support production operations, including real-time review.
- Liaise with to customers to resolve quality related issues related to customer's batches.
- Review and approve regulated documents as needed for product disposition.
- Conduct, review, and approve process and product investigations as needed for atypical events.
- Provide training on cGMPs to the QA group and Production.
The ideal candidate will have the following qualifications:
- At least 4 years of on the floor QA experience at a sterile cGMP manufacturing facility.
- Bachelor's degree, but open to lower education achieved with additional work experience.