The Fountain Group is currently seeking a --------Quality Assurance Specialist II for a prominent client of ours. This position is located in --Rockville,MD. Details for the position are as follows:
QA Specialist II
Location: Onsite (5 days/week, M–F)
Pay Rate: $26.50/hr
Duration: 6 Months (Potential Temp-to-Perm)
The QA Specialist II provides Quality Assurance oversight for GMP manufacturing operations supporting cell banks, bulk drug substances, plasmid products, and final drug products. Responsibilities include batch record review, batch disposition, deviation investigations, CAPA support, change control assessment, QA floor support, and compliance monitoring.
Key responsibilities:
Provide QA oversight for GMP manufacturing operations and client projects
Review executed batch records, QC reports, environmental monitoring data, logbooks, and cleaning records
Compile batch disposition documentation for product release activities
Support deviation investigations, root cause analysis, non-conformance management, and CAPA implementation
Evaluate and review change controls impacting manufacturing operations
Perform QA floor activities including line clearance, room release, and real-time documentation review
Conduct GMP audits and manufacturing walkthroughs
Review and disposition raw materials according to approved procedures
Issue and control batch production records and labels through QA Document Control
Ensure SOP compliance and effectiveness through direct observation
Review quality control testing documentation related to batch processing
Train junior QA staff and support continuous improvement initiatives
BS/BA in Life Sciences or a related scientific discipline
Minimum 5 years of GMP Quality Assurance experience within biopharmaceutical, pharmaceutical, or related regulated manufacturing environments
GMP batch record review and batch disposition experience
Deviation management, root cause investigations, non-conformance handling, and CAPA implementation
Change control review and quality systems support
QA floor support, line clearance, and room release activities
Product release documentation and raw material disposition
Knowledge of FDA, EMA, and ICH regulations and guidelines
QA auditing and manufacturing compliance assessments
Review of QC testing documentation and environmental monitoring records
SOP compliance and document control processes
Microsoft Excel, Word, PowerPoint, Access, and Visio
Experience with TrackWise Digital
Experience with Pilgrim quality management systems
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.