Are you in the market for your next role at a highly esteemed biopharmaceutical company? My client is seeking a Quality Specialist III professional to work at the clinical manufacturing site in Gaithersburg, MD starting ASAP. The Quality Specialist III will be ensuring quality product and timely delivery, working with the Quality team in efforts in cancer immunotherapy. The Quality Specialist III will be reporting to the Sr. Manager of Quality Assurance.
- Provide Quality Assurance support in the resolution of raw materials, in-process materials, final products, analytical, environmental, facility and equipment manufacturing issues.
- Provides oversight and input in resolving issues related to warehouse operations and manufacturing operations.
- Perform QA oversight in GMP cleanroom and laboratory environments.
- Ensure compliance to GMP regulations.
- Implement Quality Systems for deviations, CAPAs, change control, and internal auditing.
- Support the deviation system and CAPA system.
- Review and approve batch documentation, deviations, LIRs, OOS, all in compliance with SOPs.
- Support client audits, inspections, as well as new hire orientation and training content.
- Bachelors of Science with 5+ years of combined technical experience in a GMP related field
- Professional experience in a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Knowledge of training processes and regulatory requirements.
- 3+ years working within Quality Systems.
- Strong knowledge of GMPs, dispositions, deviations, CAPAs, CC and auditing practices.
- Proficiency with MS Office, electronic ERP, Quality Management Systems, Document Management Systems, and Training Management Systems.
- Excellent written and verbal communication and the ability to work in a collaborative work environment.
- Detail-oriented, self-motivated, and comfortable working independently in a fast-paced environment.
This is an onsite contract position starting at 12 months from $50-55/hour with full benefits.